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 05/12/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet cardiopulmonary is aware of a similar complaint ((b)(4)) which was investigated as follows: maquet cardiopulmonary (b)(4) received the product for investigation.A visual inspection was performed in the laboratory of the manufacturer.Thereby the reported failure could be confirmed.Furthermore a device history record review was conducted for the lot 70106595.There was no rework or scrap record performed during production activities.Moreover, a complaint review was performed for the lot 70106595.There is one another customer complaint registered in our system with another failure description.The most probable cause of the failures found is excessive physical force during transport.Based on this the failure "set arrived damaged" could be confirmed.The event has been reported with a delay due to our retrospective examination of the record.At the time (2017-05-15) 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

"when the customer received the product they discovered there was damage to the external box which continues inside and has punctured the tyvek covering." complaint #: (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: 11236694
• MDR Text Key: 258850361
• Report Number: 8010762-2021-00081
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: No Information
• Device Expiration Date: 02/06/2019
• Device Model Number: BE-HLS 7050#HLS SET ADVANCED 7.0
• Device Catalogue Number: 70104.7753
• Device Lot Number: 70116528
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/07/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1