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09 Jun 2017

CLH Blog - MHRA Field Safety Updates For May

CLH Blog - MHRA Field Safety Updates For May

As usual, we have scoured the many MHRA field safety updates that have been filed over the last month (May 2017) and have put together a roundup of all the most relevant updates and recalls. These focus on updates and alerts for health care products and equipment that are relevant to care homes in the UK, as well as to other healthcare facilities. 

Please note that the updates and alerts mentioned below are all listed with the Medicine and Healthcare products Regulatory Agency (MHRA) as well as other suppliers. Remember, if you receive a field safety notice from a supplier, it’s vital that you act upon it immediately.



Perouse Medical, Dolphin Inflation Device/Caliber Inflation Device - Voluntary Corrective Action

Perouse Medical has been informed, by a few customers, of a potential defect of the Dolphin inflation device primary packaging (blister), which may compromise the device sterility. The blister shows, in some cases, a clear crack, visible and always located at the same place (near the handle or the pressure gauge).

This field safety notice impacts certain batches of these products, these batches are catalog references 0185NA, 0185ND, 0185NR, 0185PD, 0185QL, CL3030, 0185TD, and 0185TS. The batch codes that are affected range from 1504 to 1512 and 1601 to 1612.

Perouse Medical advise that it’s best not to use any of the affected products and instead to return them back to them.

Please contact UK - Diagmed Healthcare LTD Customer Support Technician, by phone; +44 (0)1845 448184 or by email: info@diagmed.co.uk. Non-UK - PEROUSE MEDICAL Vigilance Correspondent, Ms. Claire ANDRE: by phone: +33 (0)3.44.08.17.07 or by email: candre@vygon.com

 

Aspen Medical, Sorbsan Silver Calcium Alginate Dressing - Product Recall

Aspen Medical has issued a field safety notice recalling one lot number (57903), of the Sorbsan silver Calcium Alginate Dressing following the discovery of an incorrect expiry date. The product may lack effectiveness if used past its three-year shelf life. The product is available via NHS Supply Chain as NPC ELS054.

Where purchased from NHS Supply Chain please contact your Customer Service Advisor to arrange to return for full credit using reason code 7, “Supplier Recall”.

 

Roche Diabetes Care, Accu-Chek Insight Insulin Pumps - Updated Information

To improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion, Roche Diabetes Care has updated their instruction information for their Accu-Chek Insight Insulin Pumps.

Use Energizer® Ultimate lithium batteries (1.5V AAA / FR03) provided by the manufacturer and follow the steps described in the handling instructions in the FSN. Contact Roche if you experience unexpected pump shut down or rapid battery depletion. Return the FSN acknowledgment form to Roche as currently, the manufacturer hasn’t received enough responses.

 

Cook Incorporated, Pereyra-Raz Ligature Carrier, Pereyra Ligature Carrier 75, Stamey Needle - Corrective Action

This notice relates to Pereyra-Raz Ligature Carrier™, Pereyra Ligature Carrier '75®, and Stamey Needle. COOK Medical is initiating a voluntary recall of these products. They have identified the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

A preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance. There have been no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilization associated with these devices. Potential adverse events that may occur if the products are not adequately reprocessed include localized surgical site infection to deeper organ space infection as well as chemical residual exposure.

It is recommended that all affected products are collected and discarded. Please contact Cook Incorporated via email: FieldAction@CookMedical.com to make them aware that your stock has been affected.

update: 24 April 2017 - Sutures - MHRA reference: 2017/004/026/701/006

 

Care Fusion, Alaris™ PC Unit - Advisory Notice

CareFusion has identified that the Alaris™ PC units where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped. CareFusion has identified a potential risk with the Alaris™ PC unit models 8000 and 8015. During a low battery state and if PCU is running on battery power, PCU may not always generate a low battery alarm (LB1 and/or LB2) before the battery is discharged and all infusion channels are stopped (LB3 or low battery alarm). LB1 is a message that is generated when the pump is on battery power and will operate for approximately 30 more minutes on battery power. LB2 is an alarm that occurs when the pump will operate for approximately 5 more minutes.

  • Users can plug the system into an AC outlet to operate under AC and recharge batteries.
  • Users can utilize gravity infusions outside the pump or IV syringe push in certain clinical applications.
  • Users can utilize another Alaris™ System PC unit. Clearly mark and sequester (e.g. Biomed department) the Alaris™ PC unit that exhibited a battery discharge without any low battery alarms
  • Complete Appendix 1 and return the form to your CareFusion representative. Step Action for Biomedical Engineers.

 

Dale Medical Products, Dale 270 ET Tube Holders - Reminder

Dale Medical Products has identified an issue within some Endotracheal Tube Holders (Product # 270) manufactured between March and June of 2016. As a reminder, these Endotracheal Tube Holders contain the endotracheal tube holder itself along with an adhesive “faceplate” (individual product # 273). We have found that some ET Tube Holders contain an adhesive faceplate that may lose its adhesive quality over time, and therefore not perform as it should. By “over time”, we in storage awaiting use, not after being applied.

Dale Medical Products, Inc. has performed a health risk analysis and has concluded that the overall risk to any patient with the defective device is very low, as the problem is easily detectable and causing the device to be unusable. There is no risk to patients that previously used the device without issue. However, to ensure all affected devices are removed from the field, Dale Medical Products, Inc. is initiating a recall of the 270 ET Tube Holders per our SOP-013, Recall Procedure.

Dale Medical will replace any of the affected 270 ET Tube Holders that you or your customers may still have in inventory at this time. The problem is isolated to 3 lot numbers of the 273 faceplates which were used in the following 270 device Lot Numbers produced by Dale Medical.

 

Medtronic: Pedicle Access Kit (PAK) Needles - Urgent Field Safety Notice Recall

Orthopaedic surgical instruments

Model: 8670009

Medtronic is initiating a voluntary product removal for one lot number of Pedicle Access Kit (PAK) Needles.  Possible risks of using the incorrect needle include inadvertent pedicle breach resulting in nerve root injury, which may present surgical delay and increased patient exposure time.  Please locate and remove the impacted prodcuts from normal storage locations and do not use this product.

MHRA reference: 2017/005/004/291/0030

 

Medtronic MiniMed: MiniMed 640G Insulin Pump, MMT-1711, MMT-1712 - Urgent Field Safety Notice

Infusion systems

A rare and temporary condition in which the keypad buttons on your patients' MiniMed 640G Insulin Infusion Pump may become temporarily stuck and the keypad becomes unresponsive.

This is a field safety notification and patients do not need to return or replace their pump.

MHRA reference: 2017/005/025/291/023

 

ConvaTec: Various Oxygen Masks - Recall / Product Disposal

Anaesthetic & breathing, masks

Model: 104MM 106MM 108-E 108MM 3226-E 3226MM 3230MM 9108MM

ConvaTec Unomedical has voluntarily initiated a global recall of specifi product codes and associated LOTs/batches of High Concentration Oxygen Masks.

MHRA reference: 2017/005/009/701/010

 

Rocket Medical: R22610-S - CustComp397

Suction equipment - Yankaeur Suction Tube

Product code: R22610-S

Lot number: 471722

An undetermined percentage of the above product code details have been supplied, that may contain a powder-like substance within the pack and / or tube.

Please stop use of all the devices and return stock to Rocket Medical - you can arrange to have stock collected by contacting their Customer Services on 0191 419 6988.

MHRA reference: 2017/005/005/601/002

 

BC Sendal: 2-WAY Extension Line FOR PCA, BCV, ROT.L.LOCK - 15/05/2017 Recall

Infusion & transfusion, administration sets - Urgent Field Safety Notice

Model: PCA-01

Becton Dickinson is recalling specific lots of the Extension Set PCA-01 to be used with PCA Pump, as a result of customer complaints regarding leakages at the tubing to tubing connector both during set up and during clinical use, due to an inconsistent amount of solvent applied during the manual assembly process.

The leakage may lead to an under infusion which would result in the patient not receiving the therapeutic level of medication to control their pain leading to a temporary harm.

MHRA reference: 2016/002/017/292/008

FSN Recal Ref 7

 

Mölnlycke Health Care: 23 May 2017

Medontric Sutures recall

MHRA reference: 2017/005/023/701/015

 

24th May 2017 - Nutricia Medical Devices: Flocare Gastrostomy tube (G-tube) - ENFit

Feeding systems and tubes

Model: Ch10, Ch14, CH16, Ch18, Ch20

MHRA reference: 2017/005/022/291/021

 

Hamilton Medical: IntelliCuff Standalone - 24 May 2017

Airway devices

Model: 951001

The analysis of a customer complaint has identified an issue relating to the performance of the motor in the IntelliCuff device. During use, the motor may cease to function. The alarm sounds and the red LEDs blink in all segments. The cuff must be removed from the patient.

MHRA reference: 2017/006/020/291/017

 

30th May 2017 - Medela: AXS Universal Aspiration Tubing

Suction equipment urgent recall - remove and segregate affected units for replacement

FSCA identifier: Product Field Action - 1521899

MHRA reference: 2017/006/005/291/031

 

25th May 2017 - Yellow Handled Sharp/Blunt Supasnip Scissors

Unisurge: Unisurge International Limited Supasnip Scissors

Surgical instruments, articulated cutting

Model: F811004

It has been identified that a few of the scissors detailed above have brown marks on the yellow plastic handles

MHRA reference: 2017/005/024/601/008

 

Field Safety Notice Medtronic Endo Peanut™ 5mm Device - 18/05/2017 Recall

NHS Supply Chain Code: FGP186

Medtronic is recalling specific lots of the Endo Peanut™ 5mm Device following reports that the cotton tip of the device may disengage due to insufficient adhesive application during the manufacturing process.  The use of products with this issue may increase the potential for the tip to disengage resulting in possible extension of operating room time or the need for unintended radiation exposure via e-ray for detection of the foreign body.

Customers should follow the instructions contained in the Field Safety Notice including checking all stock, cease use and quarantine prior to arranging return all affected lot numbers found.

If affected, please complete the Medtronic Verification form and return it to audrey.doyle@medtronic.com 

Medtronic FSN Recall Ref 6
 

3M™ Comply Lead Free Steam™ Indicator Tape - 25/05/2017 Recall

NHS Supply Chain Codes: EUF026 & EUF027

3M is conducting a "locate and destroy" exercise on specific lots of Comply Lead Free Steam™ Indicator Tape 1322 and 1355 shipped after 8 November 2016. This follows a technical investigation. Specific lots of indicator tape failed to meet the visual standard for colour development following exposure to steam sterilization and need to be disposed of.

Where product fails to meet the colour development visual standard, it could be interpreted that the pack had not been exposed to an adequate sterilization process.

FSN Recall Ref 10

 

Please note this is a summary of alerts for information only, please browse the Medicines and Healthcare products Regulatory Agency (MHRA) website for more. If you receive a field safety notice (FSN) from a manufacturer you must always act on it and if you have a question about a particular FSN, please contact the manufacturer. 

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