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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HQV 1806-1
Device Problem Complete Blockage (1094)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A follow-up medwatch will be submitted when additional information becomes available. Device has not been received for evaluation. Reference exemption # (b)(4). Importer: (b)(4).
 
Event Description
According to the hospital: "clot formation in arterial filter at full heparinization during ecc waste of the arterial satisfaction, without the blood flow was reduced, or no increase delta p oxygenator change of hlm incl. Set" ref. : #(b)(4), customer ref. : #(b)(4).
 
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Brand NameOXYGENATOR, CARDIOPULMONARY BYPASS
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 Key8264696
MDR Text Key133839481
Report Number8010762-2019-00016
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K132829
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 02/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/23/2020
Device Model NumberHQV 1806-1
Device Catalogue Number701042971
Device Lot Number92260005
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 Received02/06/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/01/2018
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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