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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
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FRESENIUS MEDICAL CARE NORTH AMERICA CRIT-LINE BLOOD CHAMBER Back to Search Results
Catalog Number CL10021021
Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Event Date 05/24/2013
Event Type  malfunction  
Event Description
A hemodialysis nurse reported a blood leak from the dialyzer at the crit line blood chamber connection.The connection was tightened and the patient was able to continue treatment without changing the dialyzer.The patient had less than 100ml of blood loss and did not require medical intervention.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the physician's assessment of the reported information and the plant's investigation.Related mdr: 2937457-2014-00415.
 
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Brand Name
CRIT-LINE BLOOD CHAMBER
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
kaysville UT
Manufacturer Contact
tanya taft, rn, cnor
920 winter street
waltham, MA 02451-1457
7816999000
MDR Report Key3847617
MDR Text Key4615845
Report Number2937457-2014-00414
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
Reporter Occupation Other
Type of Report Initial
Report Date 05/24/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2015
Device Catalogue NumberCL10021021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/24/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SALINE; ACIDS; BLOOD LINES; HEMODIALYSIS MACHINE; BICARBONATE
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