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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID PAD.O.FILT OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH QUADROX-ID PAD.O.FILT OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HMOD30000-USA#QUADROX-ID PÄD.O.FILT
Device Problems Restricted Flow rate (1248); Insufficient Flow or Under Infusion (2182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Return of product and patient data were requested but not yet received. A follow-up emdr will be submitted when additional information becomes available.
 
Event Description
The customer reported that they needed to change out emergently (within 24-36 hours) a quadrox-id pediatric due to high transmembrane pressures that indicate that there is a large amount of blood clot present inside the oxygenator. When this happens it affected the ability to maintain ecmo flow to the patient. Complaint id: (b)(4).
 
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Brand NameQUADROX-ID PAD.O.FILT
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
kehler strasse 31
hechingen 76437
GM 76437
Manufacturer Contact
neue rottenburger strasse 37
kehler strasse 31
hechingen 76437
4972229321
MDR Report Key11435335
MDR Text Key242778657
Report Number8010762-2021-00152
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HMOD30000-USA#QUADROX-ID PÄD.O.FILT
Device Catalogue Number70105.0330
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 Received07/06/2021
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 Initial

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