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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
Catalog Number RTLR 180111
Device Problems Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem
Event Date 05/12/2015
Event Type  Injury  
Event Description

A peritoneal dialysis registered nurse (pdrn) reported a (b)(6) female patient experienced repeated difficulty programming the cycler's iq drive. As a result of the ongoing issue the patient developed a cough and increased dyspnea on exertion for one and a half weeks. The patient was subsequently hospitalized on (b)(6) 2015. The patient was diagnosed with congestive heart failure (chf) with symptoms of fluid retention (hypervolemia). In follow-up the pdrn reported the shortness of breath was due to the patient's overall non-compliance due to two weeks of missed weekly epogen injections which would have boosted the patient's hemoglobin counts. The patient was treated with a breathing treatment and discharged on (b)(6) 2015. The epogen treatments have since been resumed. It was also noted the patient continued to have issues programming the iq drive through (b)(6)2015. On (b)(6) 2015 the patient brought the cycler to the clinic where the pdrn was able to update the cycler and iq drive programming.

 
Manufacturer Narrative

A supplemental report will be submitted upon completion of plant's investigation and clinical investigation of available medical records.

 
Manufacturer Narrative

The actual device was returned to the manufacturer for physical evaluation as the patient was able to bring the device to the clinic where the nurse corrected the issue the patient was having. In addition, an investigation of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. In addition, the device record review confirmed the labeling, material, and process controls were within specification. Medical review of the record did not reveal a correlation between the iq drive issue and admission for congestive heart failure. The patient's non-compliance to dialysis and her medication was noted as a contributing factor. Difficulty programming the cycler could have been a factor in the patient's lack of compliance to treatment.

 
Event Description

Medical records provided by the patient's treatment facility: the patient was admitted in volume overload, likely due to systolic dysfunction and noncompliance with dialysis and medications. Noted increased leg edema, orthopnea and dyspnea on exertion when walking a few feet. The patient had recently been started on albuterol mdi without any improvement. Compliance with peritoneal dialysis (pd) was a significant challenge during the inpatient stay.

 
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Brand NameLIBERTY 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 Key4855481
Report Number2937457-2015-01193
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type Health Professional,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/18/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue NumberRTLR 180111
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/01/2009
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: 06/18/2015 Patient Sequence Number: 1
Treatment
LIBERTY CYCLER CASSETTE
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