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 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not requested for manufacturer laboratory investigation as the failure is known and was investigated in a similar complaint.The investigation results of the similar complaint (703005669) are as follows: maquet cardiopulmonary gmbh 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 dhr 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 the similar complaint investigation "package was damaged in transit" could be confirmed.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.6 similar complaints were found.Due to this no systemic issue could be determined.The failure was detected during incoming inspection.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 (2018-09-27) 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 grabbed the box, she noticed there was some damage to the exterior of the box.She then proceeded to open the box to take the pack out.When the cardboard flat piece that lies on top of the sealed pack was removed, she noticed that the white film/seal had been punctured, therefore, the sterility was compromised and not usable.Complaint id (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: 11236431
• MDR Text Key: 230760304
• Report Number: 8010762-2021-00076
• 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,health professional
• 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: 10/28/2020
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 70105.2794
• Device Lot Number: 70127707
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2018
• Type of Device Usage: N
• Patient Sequence Number: 1