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 No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

Event Type  malfunction  

Event Description

Cardiohelp hls kit was primed and as therapy was initiated, no forward flow of blood could be achieved.Hls kit and cardiohelp unit were both changed at the request of the surgeon.Therapy was then able to be initiated successfully.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary requested the product in question for further investigation in the laboratory of the manufacturer on 2020-07-01.The investigation was performed on 2020-10-12.As stated in the investigation report the blockage of the rotor was caused by an extensive blood clotting, localized on the rotor surface.Thereby the rotor on pump casing.After cleaning the product, the rotor turned free and the pump function was restored.Thus the reported failure could be confirmed.With reference to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms #1468452, v23) and in consultation with the manager medical affairs the following events can contribute to clotting in the circuit: -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 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 number: (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: 10221048
• MDR Text Key: 198131466
• Report Number: 8010762-2020-00216
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other