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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ HLS 7050
Device Problem Circuit Failure (1089)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/24/2017
Event Type  malfunction  
Manufacturer Narrative
Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4). The product was disposed by the hospital; therefore a manufacturer laboratory investigation was not possible. A review for similar complaints with a product lab investigation performed was done and the following results could be obtained: the product was visual inspected in the lab of the manufacturer. Some clotted areas were visible on the outlet and inlet side. No clots were rinsed out during cleaning. The product was tested with bovine blood in the laboratory of the manufacturer for its o2, co2 transfer rate as well as for its pressure drop behavior at maximum flow. The product was operating according to the acceptance criteria's and therefore passed the test successfully. 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. 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
It was reported the customer had a circuit fail. Circuit has been thrown away with no lot # noted. Customer doesn't think it's circuits fault. Patient threw a clot. Patient is a vv pt. (b)(6). Reported internal pressure from 200 to negative 300. Pt was on for 16 hours. Grabbed another circuit and switched circuits. No patient effects. (b)(4).
 
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Brand NameHLM TUBING SET W/BIOLINE COATING
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 Key6761172
MDR Text Key81804234
Report Number8010762-2017-00253
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K101153
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
Report Date 08/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ HLS 7050
Device Catalogue Number701052794
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 Received07/24/2017
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

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