MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; 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 Date 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

The reported failure "pint and part dropped - suspected clotting" occurred during use.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 (b)(4) is not suitable for who risk group 3.Furthermore, no external laboratory could be found that could carry out the investigation on our behalf.As stated in the event description of the complaint (b)(4) it is suspect that one or more of the 4 outflow ports post centrifugal pump have become occluded secondary to clot.And also the patient was coagulopathic.As no further investigation in the laboratory of the manufacturer is possible a review of already investigated complaint was performed.A similar case was already investigate under complaint# (b)(4): as stated in the investigation report of ot# (b)(4) clots could be found inside the oxygenator.The most probable root cause for the pressure drop are clots in the oxygenator leading to a blockage and thus an extension of the diffusion path lowering the oxygenating performance.According to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # (b)(4)) 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, thrombozytopenia.Device history record (dhr) review was performed and there were no references found, which are indicating a nonconformance of the product in question.The reported failure "pint and part dropped - suspected clotting" occurred during use and could be confirmed.The device is directly involved in the event.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 cardiopulmonarys trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

It was reported from a customer from the us that customer increase the rpms to 4500 to maintain 5 lpm.Pint and part pressure on the hls module have dropped along with flow to the patient, but delta p is the same.It is suspect that one or more of the 4 outflow ports post centrifugal pump have become occluded secondary to clot.The patient is covid-19 positive, and the patient is coagulopathic.Customer will continue to support the patient on the current hls set till it fails.No information provided that there was an exchange.No indication of actual or potential for harm or death reported.Complaint id: (b)(4).

• Brand Name: TUBING SET
• Type of Device: OXYGENATOR, 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: 11094517
• MDR Text Key: 224538393
• Report Number: 8010762-2020-00461
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1