MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLM TUBING SET; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BO-HQV 15902-5#ADULT PACK

Device Problem Packaging Problem (3007)

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

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

The event has been reported with a delay due to our retrospective examination of the record.At the time ((b)(6) 2017) 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 requested the product back for investigation.The returned product was investigated in the laboratory.The set was returned without its original outer carton and protective cover for tyvek.The tyvek cover was damaged almost at the edge of the tray.Based on the visual inspection, the damage was slightly inwards.The damage could be caused by the impact from outside to inside of the package.A review of the device history record was performed with no abnormality found.No rework record was related to the claimed lot number.Packaging risks of the set have been evaluated by maquet turkey and the investigation shows that during the packaging of the set, if there is a damage on the packaging or tyvek, it will be scrapped.The product was received with no damage on the outer box.Therefore, the failure could not be related to the mcp tr production.The information obtained so far in this investigation would confirm that the device met its specification at the time of manufacturing and therefore all damages found on the product are due to excessive or inadequate external physical force that was exerted on the product after the release.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The packaging tests regarding pinhole, tear , gaps on sterile bag were performed (dms (b)(4)).According to the test result, the sterile bag was met the all requirements of visual inspection, dye penetration, peel test, seal strength and foil integrity tests.

Event Description

It was reported that the tyvek seal is damaged.Sterility can therefore not be ensured.Complaint: (b)(4).

• Brand Name: HLM TUBING SET
• Type of Device: TUBING, PUMP, 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: 11459420
• MDR Text Key: 240331693
• Report Number: 8010762-2021-00175
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K053025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 03/10/2021

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: No Information
• Device Expiration Date: 04/21/2018
• Device Model Number: BO-HQV 15902-5#ADULT PACK
• Device Catalogue Number: 70106.9140
• Device Lot Number: 92197447
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 03/11/2021
• Type of Device Usage: Initial
• Patient Sequence Number: 1