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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY GMBH QUADROX-ID PÄD.O.FILT. OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
Device Problems Restricted Flow rate (1248); Insufficient Flow or Under Infusion (2182)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 07/05/2021
Event Type  malfunction  
Manufacturer Narrative
Further patient and perfusion data was requested but not yet received. A follow-up emdr will be submitted when additional information becomes available.
 
Event Description
The customer reported that a pediatric patient was connected to a quadrox-id pedi. The blood pressure and lpm value of the patient suddenly dropped after approximately 30 h. The oxygenator was clogged and did not work anymore. The oxygenator was replaced. No harm to patient reported. Complaint id: (b)(4).
 
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Brand NameQUADROX-ID PÄD.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
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Manufacturer Contact
neue rottenburger strasse 37
hechingen 
MDR Report Key12166042
MDR Text Key261459878
Report Number8010762-2021-00396
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K132829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2021
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 Number70145550
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage

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