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

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the oxygenator was not effective, the post membrane blood gases were very bad, and did not improve.The customer had to change the circuit after a few hours, and the patient's situation improved very quickly with the new circuit.Complaint #: (b)(4).

Event Description

Complaint #(b)(4).

Manufacturer Narrative

The hls set was directly involved in the incident which occurred during patient treatment.It was reported that the oxygenator was not effective, the post membrane blood gases were very bad and did not improve.The customer had to change the circuit after a few hours and the patients' situation improved very quickly with the new circuit.The patient was infected with covid-19.Covid-19 diseases can be associated with intravascular coagulation activation, microcirculation disorders and increased risk of thromboembolism despite good systemic anticoagulation.Due to the high risk of spreading the sars-cov-2 virus outside the healthcare environment, a technical investigation of this hls set is not possible as the laboratory of maquet cardiopulmonary gmbh is not suitable for who risk group 3.Furthermore, no external laboratory could be found that could carry out the investigation on our behalf.A similar case was already investigated under complaint#(b)(4)on 2020-06-05: as stated in the investigation report of ot#(b)(4)clots could be found inside the oxygenator.The most probable root cause for the reported failure could be determined as clots which can lead to a blockage and thus an extension of the diffusion path lowering the oxygenating performance.With reference to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # 1468452, v26) 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.Thus the reported failure could be confirmed.The review of all non-conformances does not show any non-conformities in regards to the reported lot# of the hls module (70143195 ) and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences can be excluded 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.

• 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: 10913190
• MDR Text Key: 218574782
• Report Number: 8010762-2020-00408
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2021
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Device Lot Number: 70143195 (HLS MODULE)
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 11/27/2020
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1