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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 HMO 30000-J
Device Problem Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 12/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During lab investigation of complaint (b)(4) just during cleaning process of the product the blood inlet connector was fallen off. Based on this the failure could be confirmed. This additional complaint was opened in order to track and trend this observation. Trend search: a trend search was performed for p/n 70106. 3733 failure code 0402 inlet connector no additional complaint was found. Beside of this the trend search was expanded to only failure code 0402 inlet connector fallen off and no additional complaint was found. Due to this information no systemic issue could be determined. No evidence was provided that this failure was noticed within the initial complaint report. The information obtained so far in this investigation would confirm that the device met its specification at the time of manufacturing and therefore all damages found on the product are due to excessive or inadequate 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 failure was determined to be the first of its kind and is being handled through a designated maquet cardiopulmonary trending process. If a trend occurs, it will be escalated to quality assurance management for review and determination of applicable investigation. Due to this no further action will be completed at this time.
 
Event Description
During cleaning process of the product in the laboratory of the manufacture the blood inlet connector was fallen off. This was detected during investigation of complaint # (b)(4). This additional complaint was opened in order to track and trend this observation. (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 Key6148618
MDR Text Key62188062
Report Number8010762-2016-00708
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2017
Device Model NumberHMO 30000-J
Device Catalogue Number701063733
Device Lot Number70105983
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2016
Was Device Evaluated by Manufacturer? Yes
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

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