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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMOARY AG PEDIATRIC VENOUS HARDSHELL RESERVOIR
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MAQUET CARDIOPULMOARY AG PEDIATRIC VENOUS HARDSHELL RESERVOIR Back to Search Results
Model Number 70105.5117
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
On (b)(6) 2013 the customer stated, that upon opening the above product they noticed that the blood inlet connector was broken off the venous reservoir.There was no impact to a patient and this was noticed prior to a procedure.(b)(4).
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
PEDIATRIC VENOUS HARDSHELL RESERVOIR
Type of Device
VENOUS HARDSHELL RESERVOIR
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 Key4278449
MDR Text Key5294041
Report Number8010762-2014-00493
Device Sequence Number1
Product Code DTN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141432
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/04/2013
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 Date09/30/2014
Device Model Number70105.5117
Device Catalogue Number70105.5117
Device Lot Number70084314
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/04/2013
Event Location Hospital
Date Report to Manufacturer03/04/2013
Initial Date Manufacturer Received 03/04/2013
Initial Date FDA Received11/26/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2012
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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