• 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 Coagulation in Device or Device Ingredient (1096)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/13/2022
Event Type  malfunction  
Manufacturer Narrative
The event occurred in (b)(6). It was reported that the be-hmod 30000#be-quadrox-id päd. O. Filt. Got clotted on the inlet side and the delta pressure has raised to 197 mmhg in two days. The flows has been reduced drastically even with higher rpm (revolutions per minutes). Subsequently the oxygenator was changed with one from different manufacturer. No harm to any person has been reported. The affected be-hmod 30000#be-quadrox-id päd. O. Filt. Was discarded by the customer therefore a technical investigation in the getinge laboratory is not possible. A picture was provided by the customer on which the clotting on the inlet side is clearly visible. A review of the trend data for similar complaints was performed and no similar complaints were found. Based on these investigation results and the provided information by the customer, the reported failure "clotting inlet side" can be confirmed. The failure mode "clotting inlet side" can be linked to the following most possible root causes according to our risk management file: too low / insufficient anticoagulation, too low at level, effect of heparin is too limited, clotting formation on sharp edges, hemostasis, thrombozytopenia. The device history review (dhr) records were reviewed on 2022-02-18 and according to the final test results, the be-hmod 30000#be-quadrox-id päd. O. Filt. With lot#70138587 and udi#1633373 passed the tests as per specifications. Production related influences are unlikely. In order to avoid re-occurrence of the reported failure, the sales and service unit (ssu) will inform the customer to follow the chapter in the instruction for use instructions for use oxygenator quadrox-id pediatric g-140 version 06 nonus: 5. 2 safety instructions for the extracorporeal circulation no anticoagulation or insufficient anticoagulation causes occlusion of the extracorporeal circulation and the patient circuit. This can lead to inadequate patient support, hemolysis or thrombus formation in the patient. Use anticoagulants; e. G. , heparin or argatroban. Check the effect of anticoagulants at regular intervals by measuring the act (activated clotting time). Ensure that the act value does not fall below the value which is appropriate for the application. 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
The event occurred in (b)(6). It was reported that the be-hmod 30000#be-quadrox-id päd. O. Filt. Got clotted on the inlet side and the delta pressure has raised to 197 in two days. The flows has been reduced drastically even with higher rpm (revolutions per minutes). Subsequently the oxygenator was changed with one from different manufacturer. No harm to any person has been reported. 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)
JULIA KAPFENBERGER
neue rottenburger strasse 37
hechingen
Manufacturer Contact
neue rottenburger strasse 37
hechingen 
MDR Report Key13567232
MDR Text Key285928540
Report Number8010762-2022-00056
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K132829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2022
Device Model NumberBE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
Device Catalogue Number701047041
Device Lot Number70138587
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/28/2020
Is the Device Single Use? Yes
Type of Device Usage Initial

-
-