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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 BEQ-HMOD30000-USA
Device Problem Complete Blockage (1094)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2017
Event Type  malfunction  
Manufacturer Narrative
The product was visually inspected in the laboratory of the manufacturer. Clots were detected on the blood inlet side. The oxygenator was cleaned with sodium hypochlorite solution. No other abnormalities were detected. Thus the reported failure could be confirmed clotting is a known phenomenon to mcp and the cause of this incident was determined to not be attributed to a device related malfunction. Based on these results and the information available at this time, the oxygenator in question operated within mcp specifications. Since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action is needed at this time. The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process. Due to this no further investigation initiations will be completed at this time.
 
Event Description
(b)(4).
 
Manufacturer Narrative
(b)(4). The device was requested for return but not yet received. A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
Per customer- " had another oxy develop a clot on the arterial side today. It was changed but also noted the clot at the top like the last one" (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 Key7029326
MDR Text Key248144787
Report Number8010762-2017-00363
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K100278
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 12/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/01/2018
Device Model NumberBEQ-HMOD30000-USA
Device Catalogue Number701050330
Device Lot Number70114705
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/01/2016
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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