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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMOARY AG VENOUS HARDSHELL CARDIOTOMY RESERVOIRS; RESERVOIR,BLOOD,CARDIOPULMONARY
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MAQUET CARDIOPULMOARY AG VENOUS HARDSHELL CARDIOTOMY RESERVOIRS; RESERVOIR,BLOOD,CARDIOPULMONARY Back to Search Results
Model Number 02945
Device Problem Obstruction of Flow (2423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/23/2012
Event Type  malfunction  
Event Description
On (b)(6) 2012, at hospital (b)(6), after 20 minutes of starting the perfusion, a problem with the defoaming in the reservoir (lot 70069667) was identified.Due to the defoaming, the reservoir was obstructed.Reference: complaint (b)(4).
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
VENOUS HARDSHELL CARDIOTOMY RESERVOIRS
Type of Device
RESERVOIR,BLOOD,CARDIOPULMONARY
Manufacturer (Section D)
MAQUET CARDIOPULMOARY AG
kehler strasse 31
rastatt, 7643 7
GM  76437
Manufacturer (Section G)
MAQUET CARDIOPULMOARY AG
kehler strasse 31
rastatt, 7643 7
GM   76437
Manufacturer Contact
tina evancho
45 barbour pond drive
wayne, NJ 07470
9737097265
MDR Report Key4278439
MDR Text Key20453290
Report Number8010762-2014-00405
Device Sequence Number1
Product Code DTN
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K090534
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/02/2012
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 Date05/31/2012
Device Model Number02945
Device Catalogue Number70102.6499
Device Lot Number70069667
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2012
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/02/2012
Device Age5 MO
Event Location Hospital
Date Report to Manufacturer02/02/2012
Initial Date Manufacturer Received 02/02/2012
Initial Date FDA Received11/26/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/31/2011
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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