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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID PEDIATRIC OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH QUADROX-ID PEDIATRIC OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
Device Problem Gradient Increase (1270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
Event Type  malfunction  
Manufacturer Narrative
Further details on perfusion protocol, patient data and product were requested but not yet received. A follow-up emdr will be submitted when additional information becomes available.
 
Event Description
The customer reported the following: 3 kg baby, post cardiothoracic procedure. Hoked to rotaflow with behmod30000. Flow around 0. 55 liter/min. After 24 hr. The flow start to go down and the delta pressure increased. They replace the oxygenator and the tubing set to medos. Complaint id: (b)(4).
 
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Brand NameQUADROX-ID PEDIATRIC
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 Key12030727
MDR Text Key257164255
Report Number8010762-2021-00359
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeIS
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 10/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2021
Is this an Adverse Event Report? No
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 Number70134789
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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