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

Model Number BE-HLS 7050#HLS SET ADVANCED 7.0

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

Maquet cardiopulmonary is aware of a similar complaint (b)(4) which was investigated with the following results: 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 tyvek cover.After opening the tyvek cover, 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 tyvek cover and has pushed a hole in the tyvek cover 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.Most probable cause: 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.Device history record of the complained lot 70123146 has been investigated by (b)(4) and no abnormality was found.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The event has been reported with a delay due to our retrospective examination of the record.At the time (2018-07-12) 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

According to the hospital: when opening the cardboard packaging of the hls set (in order to stock the product), the pharmacy noticed a hole in the tyvek leaf.The other parts of the packaging were not damaged.No clinical consequences were reported.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: 11238486
• MDR Text Key: 229355856
• Report Number: 8010762-2021-00084
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050#HLS SET ADVANCED 7.0
• Device Catalogue Number: 70104.7753
• Device Lot Number: 70123146
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1