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

Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

Maquet cardiopulmonary is aware of a similar complaint #(b)(4) which was investigated with the following results: before opening the tub, the tensile test (checking the seal seam strength on the transport packaging) was carried out on the welded-on tyvek cover.The result was ok.During visual inspection several damages at the outer carton box were detected.Beside of this the tyvek peel cover was forced through.It was also determined that the quadrox's inlay within the tray, which is connected to the trays inner wall by welding spots, was unsoldered.Due to this the blood outlet connector of the unsecured product within the tray was able to force through the tyvek peel cover.This was most probable caused due to excessive physical force during transport.Thus the reported failure could be confirmed.A trend review was performed.17 similar complaints were found.Due to this no systemic issue could be determined.Furthermore a dhr review was conducted for the lot in question.There was no rework or scrap record performed during production activities.The product was not used for patient treatment.The event has been reported with a delay due to our retrospective examination of the record.At the time ((b)(6) 2018) 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).

Event Description

It was reported that on the tyvek cover on the hls set a puncture was noticed prior to use.No patient was involved.(b)(4).

• Brand Name: TUBING SET
• Type of Device: OXYGENATOR, 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: 11222437
• MDR Text Key: 241237118
• Report Number: 8010762-2021-00043
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2020
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Device Lot Number: 70124588
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1