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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BE-HMDO 30000#BE-QUADROX-ID PÄD.O.FILT. OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG BE-HMDO 30000#BE-QUADROX-ID PÄD.O.FILT. OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number QUADROX-ID PÄD.O.FI
Device Problems Complete Blockage (1094); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A follow-up medwatch will be submitted when additional information becomes available. (b)(4). Importer- (b)(4).
 
Event Description
According to the customer: clot formation has occurred inside the oxy. While formation of clots is common, it is uncommon for it to form on the inner clear plastic wall of the arterial side of the oxy. A surface clot is forming on the arterile side of the oxy. The position of the clot is on the inside of the clear plastic. Additional information: the incident occurred during patient treatment. (b)(4).
 
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Brand NameBE-HMDO 30000#BE-QUADROX-ID PÄD.O.FILT.
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM
Manufacturer (Section G)
BERND RAKOW
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt
GM
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt 
4972229321
MDR Report Key7586893
MDR Text Key111146183
Report Number8010762-2018-00206
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K100278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberQUADROX-ID PÄD.O.FI
Device Catalogue Number701047041
Device Lot Number70119297
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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