MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0; 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 11/13/2019

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 tube, 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 oxygenators 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.Furthermore a dhr review was conducted for the lot in question.There was no rework or scrap record performed during production activities.A trend review was performed.15 similar complaints were found.Due to this no systemic issue could be determined.The failure was detected during incoming inspection.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) 2019 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

Per customer report, :they "opened a hls set and noticed that it was damaged.It appears that whatever compromised the packaging was inside the box because the outside shipping box was intact".Complaint id: (b)(4).

• Brand Name: HLS SET ADVANCED 7.0
• 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: 11223377
• MDR Text Key: 229426306
• Report Number: 8010762-2021-00048
• 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,health professional
• 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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2021
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 70105.2794
• Device Lot Number: 70133102
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1