MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; 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 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

The hls set was discarded as it was used on a covid positive patient.According to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # 1468452, v23) following causes could lead to coagulation: 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, thrombocytopenia.As the clots are visible in the pictures which were provided by the ssu the reported failure could be confirmed.The hls set was directly involved in the incident which occurred during patient treatment.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

Patient placed on cardiohelp and hls set on (b)(6) 2020.The pressure drop across the membrane gradually increased from 25mmhg to 40mmhg (may 27th - june 2nd am) without any change in rpms the (aptt ~ 24-52 during that time period).(b)(6): heparin turned off at 10:25am for a planned tracheostomy (aptt=60).Within 1 hour (~11:30), pressure drop across membrane started incrementally increasing, rising up to 130mmhg by 12:45.Ecmo flows dropped to 1.5lpm from 3.3lpm.By the time the changeout was about to take place (~13:00), ecmo flows < 0.5lpm and delta p across membrane ~350mmhg.Gross clot visualized in pump head post-circuit changeout, with evidence of blood/blood components remaining on the actual cardiohelp console.The cardiohelp disposable at the centrifugal pump location also felt very rippled and tacky.Complaint: # (b)(4).

• Brand Name: TUBING SET
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 10163747
• MDR Text Key: 204925880
• Report Number: 8010762-2020-00203
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2021
• Device Model Number: BEQ-HLS 7050-CA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 70106.4847
• Device Lot Number: 70135241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1