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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG HLM TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Device Problems Device Alarm System (1012); Circuit Failure (1089)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/18/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The hls module advanced 7. 0 was returned to the factory and investigated in the decontamination / complaints laboratory. No blood clots were visible on flushing out the oxygenator. The dialysis connector was found to be clotted. For further examination, the product was forwarded to the qa laboratory. In the qa laboratory, the product was tested for its gas exchange performance for o2 and co2, and also a pressure drop test was performed. The product passed the gas exchange performance tests, but failed the pressure drop test, confirming the customer's reported issue. The product was then sent back to the decontamination / complaints laboratory, where all four sides of the oxygenator were sawn open, and the mats were inspected for any signs of damage, marks or any other anomalies. No anomalies were found. The number of gas mats was also counted, and there are 74 (a count of 72, 74, or 76 is specified). There were no signs of any clotting between the mats, or anything else of note. In conclusion, the results of the pressure drop test supports the customer's reported issue, however internal examination of the oxygenator found no anomalies, so a clear root cause could not be established. Based on the investigation and trending for this issue, a systemic issue is not indicated (this is an isolated case), therefore no further investigation or action is currently warranted in addition to continued periodic monitoring, and the complaint will be closed.
 
Event Description
Ref. : # (b)(4), customer ref. : (b)(4).
 
Manufacturer Narrative
(b)(4). The device has been requested but not yet received. A follow-up medwatch will be submitted if additional information becomes available.
 
Event Description
Description from the customer report: cardiohelp circuit change for venous alarms that we treated overnight with fluid boluses until customer found out this morning and insisted on changing the circuit without any further interventions. And now the flows are being read much better and venous pressure is way more appropriate. The circuit was only 5-6 days old. Not sure why this keeps happening. (b)(4).
 
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Brand NameHLM TUBING SET
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 Key5949647
MDR Text Key199045147
Report Number8010762-2016-00564
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K053025
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 07/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2016
Was Device Evaluated by Manufacturer? Yes
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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