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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY AG QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HMOD30000-USA
Device Problems Break (1069); Out-Of-Box Failure (2311)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/23/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(6) 2016 10:02 am (gmt-5:00) added by (b)(6). Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4) (b)(6). The device has not yet been received for investigation. A supplemental medwatch will be submitted when additional information is received.
 
Event Description
On (b)(6) 2016 09:56 am (gmt-5:00) added by (b)(6). Description from the customer report: "this is out of box. The arterial connection port was broken off oxygenator. Product did not reach patient. " (b)(4).
 
Manufacturer Narrative
Based on the received failure description and the picture provided by the customer the reported failure could be confirmed. The device history record for the related product has been reviewed by maquet (b)(4). The product passed every production step and was not marked as scrap. During the review of the dhr / avz no production parameters could be identified that would indicate a nonconformance during production, in regards to the reported failure. The manufacturer`s review of the quality control process indicated that a 100% functional inspection for leakage is conducted during manufacturing. The information obtained so far in this investigation would confirm that the device met its specification at the time of manufacturing and therefore all damage found on the product are due to excessive external physical force that was exerted on the product after the release. The exact root-cause which led to the described failure could not be identified. The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process. If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.
 
Event Description
(b)(4).
 
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Brand NameQUADROX-ID PEDIATRIC DIFFUSION MEMBRANE
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 Key5488923
MDR Text Key40308653
Report Number8010762-2016-00161
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCA
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 02/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2016
Device Model NumberBEQ-HMOD30000-USA
Device Catalogue Number701050330
Device Lot Number70102417
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 Received04/11/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/01/2014
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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