MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2021

Event Type  malfunction  

Manufacturer Narrative

Further details about the product and event were requested but still pending.A follow-up emdr will be submitted when additional information becomes available.

Event Description

The customer reported that an hls 7.0 had cracked.No harm to patient was reported and the product was exchanged during treatment.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that blood was leaking at the pump housing due to a crack.The device was being used for treatment.The hls set was disposed by the customer thus no technician investigation could be performed.A picture provided by the customer shows a leakage at the pump housing.A review of the trend data for similar complaints was performed and no similar complaints were found.According to the hls set risk assessment the most probable root cause was determined as a mechanical damage caused by external influences.The production records of the affected hls module were reviewed on 2021-10-27.According to the final test results, all oxygenators passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.Based on the investigation results no product related malfunction could be confirmed.The occurrence rate was calculated for the reported failure and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint id: (b)(4).

• Brand Name: HLS SET ADVANCED 7.0
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 12299841
• MDR Text Key: 265771901
• Report Number: 8010762-2021-00440
• 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
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Patient Sequence Number: 1