• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY DIALYSIS CYCLER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY DIALYSIS CYCLER Back to Search Results
Device Problem Appropriate Term/Code Not Available
Event Date 08/23/2014
Event Type  Malfunction  
Event Description

A peritoneal dialysis patient reported that he was filling slowly during treatment and the wife believes it's due to a hernia near the catheter. Patient was able to complete treatment and had no signs of infection. Nurse stated that the patient has had hernia for quire sometime. Patient had hernia repair surgery and is doing fine. Cycler was replaced.

 
Manufacturer Narrative

Medical records have been requested and have not been received by the manufacturer to date. At the conclusion of the investigation, a supplemental report will be filed with the results of the clinical investigation. The plant investigation has not yet been completed. A follow up report will be filed upon completion of the investigation.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLIBERTY DIALYSIS 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
8006621237
MDR Report Key4128803
Report Number2937457-2014-02775
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type Consumer,Health Professional,User facility,Company Representative
Type of Report Initial
Report Date 08/24/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2014
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 Received08/24/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/23/2014 Patient Sequence Number: 1
Treatment
LIBERTY DIALYSIS TUBING
PD SOLUTIONS
-
-