MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS

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

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2019

Event Type  malfunction  

Manufacturer Narrative

The sample is not available for technical investigation.

Event Description

They reported that the customer has already replaced 1 x beq hls7050ca due to clotting problems.This first circuit isn't a problem.The second circuit used was fine until they noticed that they needed to increase the rpm by 1000 to achieve prescribed flow of 5lpm.No other parameters or factors seem to have changed.When it was observed that the rpm wouldn't be sufficient, they changed the circuit again and the third one seems fine.No noticeable clotting was observed after the circuit was rinsed.(b)(4).

Event Description

Internal ref.No (b)(4).

Manufacturer Narrative

Failure description: the customer needed to increase the rpm by 1000 to achieve prescribed flow of 5lpm.No other parameters or factors seem to have changed.When it was observed that the rpm wouldn't be sufficient, they changed the circuit again and the third one seems fine.No noticeable clotting was observed after the circuit was rinsed.The customer inspected the circuit from every possible angles while it was running.Once it was removed, perfusion rinsed it and checked it again.They found nothing out of the ordinary.Investigation result: the product was not available for investigation.Therefore no laboratory investigation could be performed by the manufacturer.A review for similar complaints to be investigated already was performed and no similar complaints were found.Thus the failure could not be confirmed.The failure occurred during treatment and the product was directly involved in the incident.No root cause could be determined.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9213109
• MDR Text Key: 195616572
• Report Number: 8010762-2019-00332
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2019
• Device Model Number: BEQ-HLS 7050-CA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701064847
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2019
• Patient Sequence Number: 1