MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; 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 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not requested to return for manufacturers laboratory investigation as the failure is known already and was investigated in a previous complaint.The outcome of the previous complaint investigation was as follows: during laboratory investigation it was confirmed that the tyvek cover was forced through.Based on the previous investigation results and the received picture a confirmation of the failure was possible.The most probable cause of the failures found is 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.16 similar complaints were found.Due to this no systemic issue could be determined.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 (2017-06-22) 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

The hls set arrived at uab and was damaged.The inner, sterile barrier was punctured.Complaint # (b)(4).

• Brand Name: HLS SET ADVANCED
• 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: 11236302
• MDR Text Key: 230761398
• Report Number: 8010762-2021-00063
• 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: 01/26/2021

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: 02/23/2019
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 70105.2794
• Device Lot Number: 70116942
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1