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

Catalog Number RTLR180111

Device Problem Device Alarm System (1012)

Patient Problem Peritonitis (2252)

Event Date 10/31/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the clinical investigation and device manufacturer's evaluation.

Event Description

A continuous cycling peritoneal dialysis (ccpd) patient's nurse called technical support regarding various cycler alarms for the patient who had been admitted to the hospital.Upon follow with the patient's pd nurse, she confirmed that the patient was admitted to the hospital for peritonitis and discharged to home on (b)(6) 2015.It was suspected that the peritonitis is related to a break in aseptic technique as one of the hospital rn's disconnected and reconnected the patient line during treatment.Medical records requested.

Manufacturer Narrative

On (b)(6) 2015, the patient was seen at the physician office.At the office, the patient was found to have cloudy dialysate from his peritoneal dialysis catheter with a mildly elevated white blood count.Patient wa afebrile and never appeared septic so, the patient was transferred back to his facility.Upon hospital admission, the patient's dialysate fluid demonstrated abnormally high white blood with concomitant elevated neutrophils.The patient was started on intraperitoneal antibiotics for two weeks.Patient was treated and discharged on (b)(6) 2015.Medical records do not contain a history and physical admission notes, progress notes, medication records or dialysis treatment notes for review.Although medical records indicate the cause of peritonitis is from peritoneal dialysis, the medical records do not indicate the source of the infection.Documentation in the medical records does not indicate a causal relationship between the patient's liberty cycler and the patient's peritonitis.There is no documentation in the medical record that the peritonitis occurred as a result of a leak or other malfunction.

Event Description

Medical records reveal patient was discharged on (b)(6) 2015.The pdrn suspected that the peritonitis maybe related to a brak in aseptic technique that the patient reported to her as one of the hospital rn's disconnected and reconnected the patient line during a treatment.

Manufacturer Narrative

The actual device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformance during the manufacturing process.Product labeling, material, and process controls were within specification.

• 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 ; 7816999751
• MDR Report Key: 5340382
• MDR Text Key: 35008434
• Report Number: 2937457-2015-01757
• 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: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2015

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: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/31/2015; 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 86