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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HMOD 70000-USA
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4). A supplemental medwatch will be submitted when additional information becomes available. (b)(4).
 
Event Description
During support of a patient on a softline-coated quadrox-id oxygenator, the clinicians perceived an inability to adequately flow forward. The oxygenator was changed out with a new one of the same part number/coating and no issues were perceived. Additional info received on 12/15/2015: treatment was not delayed. A systematic decision was made by the surgeon and the perfusion team first. There were no visible signs of clotting on either side of the oxygenator. The centrimag blood pump was used. The flow was as high as 3. 25 lpm. The oxygenator had only been in use for approximately 1. 5 hours. (b)(4).
 
Manufacturer Narrative
The device history record for the reported oxygenator has been reviewed. The product passed every production step and was not marked as scrap. During the review of the dhr no issues with production parameters could be identified that would indicate a nonconformance during production, in regards to the reported failure. Investigation is still pending. A supplemental medwatch will be submitted as soon as further information becomes available.
 
Event Description
(b)(4).
 
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Brand NameQUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR
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 76437
GM 76437
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt 76437
4972229321
MDR Report Key5353573
MDR Text Key35354040
Report Number8010762-2016-00015
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K101153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2017
Device Model NumberHMOD 70000-USA
Device Catalogue Number701053815
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/18/2016
Event Location Hospital
Date Report to Manufacturer12/14/2015
Date Manufacturer Received04/18/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/01/2015
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: 01/08/2016 Patient Sequence Number: 1
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