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

Model Number BEQ-PVL 2555-USA

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

The event has been reported with a delay due to our retrospective examination of the record.At the time (2019-11-23) the complaint was reviewed and found not to be reportable.Current day, we compared the record with equivalent events, and found an inconsistency with the reporting decisions.With the current knowledge and the current team of complaint handlers, we have come to conclude the event should have been reported.As a remedial effort, we will report it within capa # (b)(4).Maquet cardiopulmonary gmbh did not request the product back for investigation since the issue is known.Similar product, showing a similar malfunction, has been investigated in # (b)(4): a hole in sterile bag on paper side can be confirmed.No welding problem was found.In addition photo of the complaint shows the torn on the medical paper side of the sterila package.Device history record for lot 92286425 was reviewed.There are no evidences indicating a non conformance or deviations of the product in question during the manufacturing and final release of this specific lot.The failure is already known to the manufacturer.Maquet cardiopulmonary gmbh has been already initiated a capa (b)(4), 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.This complained product was manufactured before the corrective actions are implemented in capa.The most probable root causes were identified in dms # (b)(4) version 01.One of the root causes is, primary packaging consist out of medical paper pouch which do show less protection than other materials like tyvek.Based on this, engineering change request # (b)(4) has been initiated to change sterile bag from medical paper to tyvek and strengthen cardboard box.Based on this failure could be confirmed.This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary gmbh and further investigations and measures will be conducted in case of adverse trending.

Event Description

It was reported that upon opening the boxes the packaging of product was found torn.Complaint # (b)(4).

• Brand Name: CATHETERS & CANNULAE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 11432603
• MDR Text Key: 240051199
• Report Number: 8010762-2021-00139
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2021

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: 08/02/2021
• Device Model Number: BEQ-PVL 2555-USA
• Device Catalogue Number: 70106.3787
• Device Lot Number: 92286425
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 03/08/2021
• Date Device Manufactured: 08/03/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1