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02 Dec 2016

CLH Blog - MHRA Field Safety Updates For November

CLH Blog - MHRA Field Safety Updates For November

Once again, we’ve put together a roundup of field safety updates from the last month. This is our eighth post of field safety updates, and like usual, it focuses on all the most recent health care product updates and alterations that are relevant to UK care homes.

These are all things that are listed with the Medicines and Healthcare products Regulatory Agency (MHRA) amongst other suppliers.

November’s alerts:

CME: Ambulatory Syringe pumps - T34, T60 and TPCA - FSN2016-004 Field Safety Notice

Following the previous field safety notice that related to the above syringe pumps coming into contact with direct sunlight, CME Limited has revised the operating manuals for the pumps.

The syringe pump must always be used in a CME Ltd pouch if being used in direct sunlight. If the pump is exposed to direct sunlight, it may affect functionality. CME will ensure that all pumps have labels explaining this change on them - users should adhere to these labels.
 

For more information about this alert and what action to take, please see here.

Leonhard Lang: Defibrillation electrode SCHILLER DF87C and Defibrillation electrode SCHILLER DF56C - FSN-16-0081 Product Recall

During an investigation triggered by customer feedback, it was discovered that the use of the above mentioned defibrillation electrodes with the defibrillator DEFIGARD TOUCH 7 may lead to a cable break.

This cable break depends on the operating conditions and is caused by the repeated opening and closing of the device bag. Investigations have shown that this defect may occur after more than 400 opening and closing cycles at the earliest under certain aggravated mechanical conditions. All affected products should be returned to Leonhard Lang as soon as possible by using the form “FSN Report 1” on the Leonhard Lang website. 

For more information about this alert and what action to take, please see here.

3M™: Universal Electrosurgical Pad, reference number 9130 - Safety Information

This Field Safety Corrective Action follows confirmation of a single user report of an unintended material (process liner) in the product. The presence of a process liner may prevent or impede the safe return of electrosurgical current following Electrosurgical Unit (ESU) activation. While there is only a remote possibility of the pads containing the process liner, 3M is requesting your prompt assistance for this FSCA.


This defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body due to increased impedance at the pad application site. The devices that are affected should be disposed of immediately. 

For more information about this alert and what action to take, please see here.

Medtronic Ltd: Laparoscopic Camera Cleaning Clearify™ Visualization System - Product Recall

Medtronic Ltd have recalled specific lot numbers of the laparoscopic camera cleaning Clearify™ Visualization System following a discovery of a potential compromise in packaging which could cause a breach in the sterile barrier.

Use of a damaged product could increase the risk of infection. To report affected products, email lisa.charley@medtronic.com or fax 44 (0) 1923 241004. Medtronic will arrange to collect products and will issue credit for them.

Handicare AB: Non-Conforming Coach Bolt - Safety Information

It has come to Handicare ABs knowledge that a limited amount of coach bolts attaching the ceiling mil to Vertical Supports may fracture. The fracturing of the coach bolts may cause the rail and the Vertical Support to detach from each other. The affected coach bolts were delivered to customers from August 31 until October 271b in 2016.
Affected Products: 90002944 Coach bolt M10x30 D1N603 Fzb Coach bolt are marked “NEXO 4.3’ on the bolt cap. The bag containing affected coach bolts are dated August 2016 to October 2016 on the label. Coach bolts dated otherwise or with other markings are not affected. Any coach bolts that are affected must not be used and should be disposed of. Any affected coach bolts that have already been fitted should be removed and replaced by a qualified technician.

For more information about this alert and what action to take, please see here.

Bayer PLC: Source Administration Sets (SAS) used with the Medrad® Intego PET Infusion System [Catalog Number INT CSS] - Safety Information

We have determined that all current Source Administration Sets (SAS) used with the Medrad® Intego PET Infusion System may produce particulates in radiopharmaceutical (RP) vials when the needle is inserted. The particulates may be generated when the tip of the needle pushes through the rubber septum of the vial. This presents a potential safety risk of particulate(s) being injected into a patient.

We are advising you to immediately discontinue use of your Intego system and quarantine the SAS disposable units that you have in stock. For any questions, please email ukcustomersupport@bayer.com. 

For more information about this alert and what action to take, please see here.

Acutronic Medical Systems: Fabian HFO and Fabian Evolution - Corrective Action

Acutronic received a customer complaint. In conjunction with the Sp02 option, it has been found that sometimes the SPI interface can freeze, leading to a situation where the GUI freezes and ventilation will stop. The ventilator will set off an alarm that combines and alarm sound with a blinking red LED.

A software bug fix will soon be issued. Until then, it is advised not to use the Sp02 option.  

For more information about this alert and what action to take, please see here.

Please note this is not a definitive list of field safety alerts, please visit the MHRA website for more.

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