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

Model Number BE-HLS 7050#HLS SET ADVANCED 7.0

Device Problems Coagulation in Device or Device Ingredient (1096); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that an hls module clotted during use and flow was reduced.The hls set was replaced during treatment.Complaint #(b)(4).

Manufacturer Narrative

It was reported that during treatment clotting of ecmo oxygenator, followed by rise in internal pressure (pint) and delta p occurred , resulting in reduction of flows in used ecmo circuit.The hls set was replaced.The reported clots lead to a blockage and thus an increased delta pressure and reduced flow.According to our risk management file (hls set advanced 5.0 / hls set advanced 7.0, dms # 1468452, v26) following most possible root causes can lead to clotting: de-airing luer lock connection too loose; air remains in or enters the circuit; hemostasis; air or blood remains in luer lock access port; too low anticoagulation; too low at level, effect of heparin is too limited; protamine sulfate enters the hls set; administration of substitution of congealable substance such as plateles; (consumption) coagulopathy; thrombozytopenia.The production records of the affected hls module (dms#2941189 and 2956715 ) were reviewed on (b)(6) 2021.Following tests are performed according to the bop as a 100 % inspection: leak test after welding; pressure test heat exchanger; leak test water side; leak and flow test gas side; pressure test blood side; coating test.According to the final test results, all oxygenators passed the test as per specifications.Production related influences can be excluded.Based on these investigation results the reported failure ¿clotting¿ could be confirmed.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 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 # (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: 11145379
• MDR Text Key: 227110379
• Report Number: 8010762-2021-00006
• 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
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• 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: 701047753 (HLS SET)
• Device Lot Number: 70138118 (HLS MODULE)
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 45 YR