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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER
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FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Colostomy (2552)
Event Date 12/09/2014
Event Type  Injury  
Event Description
A peritoneal dialysis patient's wife reported that patient's drain bag fluid was cloudy and that the patient had peritonitis.The patient's wife stated that the patient was on antibiotics.A follow up call was made to the peritoneal dialysis nurse.Per the nurse the patient was diagnosed with peritonitis on (b)(6) 2014.The patient was treated with intra-peritoneal vancomycin.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of plant's investigation.
 
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Brand Name
LIBERTY CYCLER
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
concord CA
Manufacturer (Section G)
FRESENIUS MEDICAL CARE NORTH AMERICA
4040 nelson ave
concord CA 94520
Manufacturer Contact
tanya taft, rn cnor
920 winter st
waltham, CA 02451-1457
7816999000
MDR Report Key4505927
MDR Text Key5443567
Report Number2937457-2015-00135
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
PMA/PMN Number
K043363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Type of Report Initial
Report Date 01/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received01/07/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
DELFLEX PD SOLUTION; LIBERTY TUBING
Patient Outcome(s) Required Intervention;
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