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 Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Within 15 minutes of being on the cardiohelp hls circuit, the delta p started rapidly rising to > 50 and soon after, blood flow rates were affected.Unable to get flows above 1 lpm.The circuit offered enough support to get the patient to (b)(6), where they rapidly exchanged the circuit for another one.This exchange occurred less than 2 hours from initiation of therapy.Providers flushed out the failed oxygenator and did not see any obvious clots that would explain the rapid failure.Complaint id: (b)(4).

Manufacturer Narrative

The device history record of the affected product was reviewed and no references were found, which are indicating a nonconformance of the product in question.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.A similar case was already investigated under complaint#: (b)(4) on (b)(6) 2020: as stated in the investigation report of ot#: (b)(4) clots could be found inside the oxygenator.The most probable root cause for the increased pressure drop are clots in the oxygenator leading 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, v24) 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 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: 10406085
• MDR Text Key: 202948801
• Report Number: 8010762-2020-00257
• 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: 08/26/2020

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 Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 1568468
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 08/26/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1