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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; TUBING, PUMP, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BE-HQV 49500
Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/23/2014
Event Type  malfunction  
Event Description
It was reported that ten minutes after initiation of therapy a leak from the gas outlet was observed.Approx 3 ml of blood was lost.Therapy was administered for 186 minutes.The device was fully functional in terms of oxygenation and ventilation.No reported pt effect.(b)(4).
 
Manufacturer Narrative
Maquet cardiopulmonary is aware of similar complaints.The devices displayed a similar malfunction which were tested and evaluated under an optical microscope.Delamination of some gas fibers was observed which allowed for the priming solution or blood to flow inside the gap between the gas fibers and polyurethane.Gravity then allowed for passage to the gas exiting path along the housing.The most probably root cause is the delamination of the hollow gas fibers from the polyurethane potting area.A review of the quality control process confirms that 100% functional inspection for leakage is performed during production.Maquet cardiopulmonary (b)(4) has initiated an internal process ((b)(4)) to address the appropriate corrective and preventive action.A supplemental medwatch will be submitted when new info becomes available.
 
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Brand Name
HLM TUBING SET W/BIOLINE COATING
Type of Device
TUBING, PUMP, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
Manufacturer Contact
michael campbell
kehler strasse 31
rastatt 76437
GM   76437
2229321132
MDR Report Key4259043
MDR Text Key5050683
Report Number8010762-2014-01062
Device Sequence Number1
Product Code DTL
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K080592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 09/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/01/2016
Device Model NumberBE-HQV 49500
Device Catalogue Number70102.5888
Device Lot Number92141520
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/30/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/23/2014
Initial Date FDA Received10/22/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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