• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOPULMONARY GMBH OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
Device Problem Failure to Deliver (2338)
Patient Problems Death (1802); Thrombosis/Thrombus (4440)
Event Date 01/18/2021
Event Type  Death  
Manufacturer Narrative
A follow up medwatch will be submitted when additional information becomes available.
 
Event Description
It was reported from a customer from thailand that during va ecmo after 20 minutes ecmo circuit have clot in the be-hmod 30000 oxygenator (pre-membrane). Result is flow drop (about 0. 02 lpm), pressure p2 measure too high. Checked central cannulae a 10 fr. , v 18 fr. Don't have clot and good position. Diagnosis tga, post operation aso , cpb time 300 min. Can't off cpb go to ecmo. Harm or death of patient or operator reported. The patient expired. Complaint id: (b)(4).
 
Manufacturer Narrative
It was reported from a customer from (b)(6) that during va ecmo after 20 minutes ecmo circuit have clot in the be-hmod 30000 oxygenator (pre-membrane). Result is flow drop (about 0. 02 lpm), pressure p2 measure too high. Checked central cannulae a 10 fr. , v 18 fr. Don't have clot and good position. Diagnosis tga, post operation aso , cpb time 300 min. Can't off cpb go to ecmo. Harm or death of patient or operator reported. The patient expired. The affected hmod 30000 with lot# 70144395 was requested for further investigation in the getinge laboratory. It was received on 2021-03-08 and during the technical investigation on 2021-03-15 the reported failure "clots in the oxygenator" could not be confirmed as the oxygenator was completely spilled out. To rule out a product malfunction a leak test was performed and no leakage was noted. For further investigation patient data was collected and a medical review was performed by getinge medical affairs specialist on (b)(6) 2021 with the following result: it follows from the details available in the complaint that the increase of the premembrane pressure (with low flow) was the response to clotting of the oxygenator. The clotting observed by the customer, however, was likely associated with the administration of protamine, ffp and platelets 10 minutes after the initiation of ecmo support. The instructions for use oxygenator quadrox-id pediatric | 1. 6 | g-306 | 05 contained the following. "the administration of coagulant protamine causes occlusion of the extracorporeal circulation and the patient circuit. This can lead to inadequate patient support, hemolysis or thrombus formation in the patient¿. The administration of protamine during extracorporeal support is strongly discouraged as its administration may lead to thrombus formation in either the patient and/or the extracorporeal circuit. The expiration of the patient appears to be the confluence of events including ¿massive¿ hemoptysis, the administration of procoagulants, the cessation of blood flow, and the inability of the patient to tolerate the combination of these circumstances. Further, the expiration of the patient does not appear to be directly associated with the oxygenator per se. A device history review (dhr) was performed and the dhr does not show any abnormality or issue that is related or can have led to the customer complaint. Based on the investigation results the reported failure "clots in the oxygenator" could be confirmed but no product related malfunction. The most probable root cause could be determined as a coagulation of the membrane caused by administration of protamine during extracorporeal support. The coagulation can lead to a blockage and thus an extension of the diffusion path lowering the oxygenating performance and decreasing the flow. 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 id: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOXYGENATOR
Type of DeviceOXYGENATOR, 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 Key11207146
MDR Text Key227928314
Report Number8010762-2021-00020
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K132829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
Device Catalogue Number701047041
Device Lot Number70144395
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/21/2021 Patient Sequence Number: 1
-
-