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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERT CYCLER
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FRESENIUS MEDICAL CARE NORTH AMERICA LIBERT CYCLER Back to Search Results
Device Problem Device Handling Problem (3265)
Patient Problem Colostomy (2552)
Event Date 02/19/2015
Event Type  Injury  
Event Description
A peritoneal dialysis pt's nurse reported that on (b)(6) 2015, the pt went to the hospital for abdominal pain and was admitted with peritonitis from touch contamination.The pt was treated with unk ip antibiotics while in the hospital.The pt was discharged on (b)(6) 2015.The pt was continued with peritoneal dialysis.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the plant's investigation.
 
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Brand Name
LIBERT 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
920 winter st
waltham, MA 02451-1457
7816999000
MDR Report Key4687026
MDR Text Key17295478
Report Number2937457-2015-00468
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2015
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2010
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
DEFLEX PD SOLUTION; LIBERTY TUBING
Patient Outcome(s) Hospitalization;
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