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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 Device Handling Problem (3265)
Patient Problem Colostomy (2552)
Event Date 03/17/2015
Event Type  Injury  
Event Description
A peritoneal dialysis patient's wife reported that the patient was not feeling well.A follow up call was placed to the patient's peritoneal dialysis nurse.The nurse reported that the patient was diagnosed with a touch contamination peritonitis on (b)(6) 2015.The culture report showed ecoli and group d non enterococcus.The patient was treated with vancomycin and ciprofloxin.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the 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, MA 02451-1457
7816999000
MDR Report Key4705806
MDR Text Key5718700
Report Number2937457-2015-00505
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
PMA/PMN Number
K034462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Type of Report Initial
Report Date 03/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received03/17/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2010
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
LIBERTY TUBING; PD SOLUTION
Patient Outcome(s) Required Intervention;
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