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 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

Maquet cardiopulmonary is aware of a similar complaint (b)(4) which was investigated with the following results: during laboratory investigation it was confirmed that the tyvek cover was forced through.Based on the previous investigation results a confirmation of the failure was possible.Thus the failure could be confirmed.Due to repeating nonconformities in regards to the packaging of several product a capa process (capa-(b)(4)) was started.The beq-hls 7050 usa is also in scope of this capa.The capa is currently in investigation / root cuse analysis phase which is due by 2018-02-28 in regard to the intellipack 1 packaging system.All further investigation initiations and corrective actions will be performed out of the capa process.In regards to the issue concerning the punctures from inside to outside an inappropriate handling (upside down) can be concluded.If the welding points of the inlay become loose, it will allow the product within the inlay to move.As a consequence, the holder of the venous probe may cause damages in terms of two punctures through the tyvek cover.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time the event has been reported with a delay due to our retrospective examination of the record.At the time (2018-01-12) 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 customer noticed the seal to the tray was damaged when they open the 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: 11221878
• MDR Text Key: 230760863
• Report Number: 8010762-2021-00035
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K102726
• 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?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1