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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 3900
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/09/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
There was an oxygenator failure after approximately 4. 5 hours on cpb. At 32 degrees the po2 was 24 at fio2 89 (checked on abg x 2). Upon warming just 0. 4 degrees and turning the fio2 up further the po2 continued to decrease. The fio2 was turned to maximum and the po2 continued to decrease on the cdi. The patient was cooled back to 32 degrees while preparing the new oxygenator. The change out was completed within 2 minutes. The po2 increased and maintained at ¿normal¿ fio2 levels with the new oxygenator. (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 Key7306616
MDR Text Key101598093
Report Number8010762-2018-00077
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K082117
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 06/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/19/2019
Device Model NumberHQV 3900
Device Catalogue Number701053616
Device Lot Number92228019
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/01/2018 Patient Sequence Number: 1
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