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 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

Maquet gmbh requested the product for investigation in the laboratory of the manufacturer.2018-06-13: the product was investigated in the laboratory of the manufacturer with the following outcome: when delivered, still original packed, beq-hls 7050 usa # hls set advanced 7.0 was carried out on the outer packaging and on the inner packaging, a visual inspection was performed.The results of the investigation were documented in writing and figuratively.During the visual inspection of the returned set, various transport damages (holes, dents) were found on the outer packaging.The inner packaging (tray) has no damage except the hole in the tyvekcover.After opening the tyvekcover, it became apparent that the welded inlet to the tray had come off.The oxygenator fixed in the insert can thus move upwards towards the tyvekcover and has pushed a hole in the tyvekcover with the catch on the blood inlet connector and thus interrupted the sterility of the set.Due to this the blood 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.20 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 ((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 the tyvekcover was damaged as the customer opened the outer box.Complaint id: (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: 11222490
• MDR Text Key: 231583274
• Report Number: 8010762-2021-00045
• 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
• 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: 02/27/2020
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Device Lot Number: 70123206
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1