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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENTOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG OXYGENTOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HMOD30000-USA#Q
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/29/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A follow-up medwatch will be submitted when additional information becomes available. (b)(4). The product was requested for return to the manufacturer for laboratory investigation but all four oxygenators are not any longer available. Therefore no laboratory investigation could be performed by the manufacturer. A review for similar complaints to be investigated already was performed and no similar complaints were found. 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. Thus the reported failure could not be confirmed the most probable root cause is unknown. Based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction. According to information of the territory manager on (b)(6) 2018 each oxygenator was approximately 5 days in use. According to the ifu g-149 v04 chapter 2 "the maximum duration of use is 6 hours. " 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
According to the customer: oxygenator requiring change out for clotting every 5-6 days. The clotting was noticed on the inlet side. During one procedure five oxygenators were affected with the same problem. But only one of the five oxygenators is available for investigation. Oxy with the lot #70121445 will be return to the manufacturer. This oxygenator will handle in (b)(4). For the other four oxygenators a separate complaint was opened. This will be handled under (b)(4) in this report. The lot numbers of the four oxgenators are unknown and the oxygentors are not available for investigation. Incident required exchanges the oxygenators during use. No harm to the patient was reported. (b)(4).
 
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Brand NameOXYGENTOR, 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 Key7638106
MDR Text Key112559955
Report Number8010762-2018-00219
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 07/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HMOD30000-USA#Q
Device Catalogue Number701050330
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/26/2018 Patient Sequence Number: 1
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