MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CANNULA & CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BE-PVL 2555#

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing.A follow-up medwatch will be sent when further information becomes available.

Event Description

It was reported that there was a hole in the sterile bag at the medical paper side.The product was not used on patient.Complaint #: (b)(4).

Event Description

It was reported that there was a hole in the sterile bag at the medical paper side.The product was not used on patient.Complaint #: (b)(4).

Manufacturer Narrative

The hls cannulae was directly involved in the incident which was detected during unpackaging.It was reported that there was torn at hls cannulae sterile package.The product has been investigated on 2021-10-07 in the laboratory of manufacturer.Visual inspection was performed.According to the visual inspection the punctured area on the sterile package confirmed.The hole was measured with a vernier caliper and dimensions were found as approximately 15 mm x 13 mm.No further damage was found on the sterile package.The complaint could be confirmed based on test results.Device history record for lot 92301443 was reviewed.There are no evidences indicating non-conformance or deviations of the product in question during manufacturing and final release of this specific lot.The issue is known to manufacturer.Maquet cardiopulmonary gmbh has been already initiated a capa, based on several complaints showing the same symptoms with different material numbers than the one in this complaint, in order to determine the root cause and initiate further actions to determine corrective measures for the failure.The photographs within the complaint and in the capa's have been compared and found similar.The root cause has been identified and the actions have been implemented in the capa.Sterile package has been changed and implemented into the production on 25 aug 2021.The reported lot number was manufactured before sterile package change implemented into the production.No further action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: CANNULA & CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11954676
• MDR Text Key: 254802930
• Report Number: 8010762-2021-00333
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2022
• Device Model Number: BE-PVL 2555#
• Device Catalogue Number: 701047296
• Device Lot Number: 92301443
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 10/18/2021
• Patient Sequence Number: 1