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04 Dec 2018

CLH Blog - MHRA Field Safety Updates For November 2018

CLH Blog - MHRA Field Safety Updates For November 2018

As always, we have researched the various field safety alerts that have been filed over the past month and have put together a roundup of the most relevant MHRA updates and recalls. These focus on recalls and updates on products and equipment that are relevant to UK care homes and other care facilities.

Please note that the updates mentioned below are all things listed with the Medicines and Healthcare products Regulatory Agency (MHRA) amongst other suppliers. Please also note that if you receive a field safety notice from a supplier, it is vital that you act on it immediately.

Canon XR System DRAD-3000E/W8 s/n W8A13X2001 Radrex with Wireless FPD - Field Safety Notice

Affected systems are DRAD-3000E with TFP-4336W wireless Flat Panel Detector, Software version. V5.00ER005 with specific serial numbers. The number affected in your case is shown in the title.

Description of the problem on affected products:

It has been found that when an operator performed radiography with the wireless X-ray detector TFP4336W, a message window was displayed on a monitor that said “image transmission had not completed” No X-ray image was displayed. It also showed "OK" button to re-acquire image data from the X-ray detector and "Cancel" button to cancel the re-acquisition. When the operator selected "OK" button the same message window appeared again. The operator repeated this several times but finally he/she selected the "Cancel" button to quit the re-acquisition mode. After the system was restarted, it worked normally. However, after the restart, image data was lost. This issue was identified due to a software problem in the wireless FPD control when congestion of the wireless channel occurs which disrupts communication.


Cardinal Health - Protexis Neoprene Surgical Gloves - Field Safety Notice | FSN Date: Novemer 2018

Cardinal Health is initiating a product labeling correction for specific item codes and production lots of Protexis Neoprene Surgical Gloves. This Field Safety Corrective Action (FSCA) is being conducted due to incorrect breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the “wallet” (primary packaging). Additionally, breakthrough time for Mitomycin was added to the same label in error. Refer to table below for technical data comparison.

The incorrect permeation times for Carmustine and Thiotepa poses the potential risk of chemical exposure to users. In addition to localized skin irritation, blistering and burn-like effects, systemic symptoms can occur with prolonged or repeated exposure. To mitigate risk, clinicians should assess the drug toxicity and exposure time prior to handling. It is recommended that two common clinical practice standards be utilized: double gloving and changing gloves every 30 minutes. Cardinal Health has not received any related complaints for the affected product to date. Cardinal Health’s records indicate you may have received product associated with this action. Please ensure the Required Actions are completed for the affected product codes and lots for this action.


Incorrect FastFinderTM Suffix in User Manuals - Field Safety Update | FSN Date: November 2018

Details on affected devices:

FTlyo 2+.1 Respiratory pathogens 21 plus, user manual “FTlyo 2+.1-32_64-MANUAL-v2-2018_02”
FTlyo 2P.3 Respiratory pathogens 33, user manual “FTlyo 2P.3-32_64-MANUAL-v3-2018_10”
FTlyo 48.1 FLU/HRSV v.2, user manual “FTlyo 48.1 - 32_64 - MANUAL - v2 - 2018_05 EN”
FTlyo 56.1 HCoV v.1, user manual “FTlyo 56.1 - 32_64 - MANUAL - v1 - 2018_01 EN”

Description of the problem:

FTD has become aware that the information contained in the user manuals listed above contains incorrect information regarding the use of FastFinderTM. Specifically, the tables entitled “Setting sample, control and detector programming” contained incorrect information regarding the suffixes and final programming of the samples and control for FastFinderTM. If the incorrect suffix appearing in the user manuals is entered into the FastFinderTM software, a partial analysis or no analysis of the plate would be completed by the software, leading to no analysis of the Primer Probe mixes of affected wells. Table 1 summarizes the pathogens that may be absent from analysis when the incorrect suffix is used.


Pennine - Prestrol Suction Catheter – FG/CH 7 (2.3mm), 48cm - Field Safety Update | FSN Date: November 2018

Through post production experience activities we have identified that there is a small possibility that the suction catheter may be blocked. A blocked suction catheter would mean that suctioning could not be performed. There is a potential for serious harm should an alternative suction catheter not be available.

Actions to be taken by the user:

  1. Identify and quarantine all stock of the affected batch.
  2. Complete the attached reply form to confirm that you have read and understood the contents of this Field Safety Notice.
  3. Upon receipt of the completed reply form, Pennine Healthcare will arrange for the return or destruction of the affected product.
  4. Replacements will be provided for the affected stock which you are holding.
  5. Maintain awareness of this Field Safety Notice until all stock of the affected batch has been destroyed or returned to Pennine Healthcare.

Transmission of this Field Safety Notice: This notice should be passed on to all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred.


We’ll be back again next month with all of the latest MHRA field safety updates. Seen an alert we’ve missed? Tweet us @CLHGroup to let us know and don’t forget to use '#CommittedToCare' in your posts.

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