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

Catalog Number RTLR 180111

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Congestive Heart Failure (1783)

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.

• 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 Key: 4855481
• MDR Text Key: 5874205
• Report Number: 2937457-2015-01193
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR 180111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 06/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER CASSETTE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 90