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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CRIT-LINE BLOOD CHAMBER; KOC
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FRESENIUS MEDICAL CARE NORTH AMERICA CRIT-LINE BLOOD CHAMBER; KOC Back to Search Results
Catalog Number CL10021021
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/29/2015
Event Type  malfunction  
Event Description
A hemodialysis user facility has reported that during treatment a blood leak occurred once the crit-line blood chamber loosened from the arterial end of the dialyzer.The leak was visually observed to be below the wings of the pvc adaptor around the threaded area that connects to the dialyzer.Estimated blood loss was less than 30cc.The patient had no adverse effects and no medical intervention was required.The patient completed treatment.Sample has not been returned to mfr for evaluation.
 
Manufacturer Narrative
Plant investigation has not yet been completed.A f/u report will be filed upon completion of the investigation.
 
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Brand Name
CRIT-LINE BLOOD CHAMBER
Type of Device
KOC
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
concord CA
Manufacturer Contact
tanya taft, rn cnor
920 winter st
waltham, MA 02451-1457
7816999751
MDR Report Key4834534
MDR Text Key16307989
Report Number2937457-2015-01135
Device Sequence Number1
Product Code KOC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K935958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCL10021021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/13/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FRESENIUS 2008T HEMODIAYSIS MACHINE
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