MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

Device Problem Device Handling Problem (3265)

Patient Problems Urinary Tract Infection (2120); Peritonitis (2252)

Event Date 02/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A supplemental report will be submitted upon completion of a clinical investigation of medical records and the plants investigation.

Event Description

A (b)(6) old patient with end stage renal disease (esrd) on peritoneal dialysis therapy caregiver reported to technical support the patient was hospitalized due to a peritoneal infection.During a follow-up call with the patient's peritoneal dialysis registered nurse (pdrn) it was confirmed the patient was diagnosed with peritonitis, pneumonia and a urinary tract infection (uti) on (b)(6) 2016.The patient was treated with an unspecified medication (drug name, dose, route, and frequency unknown).The patient's peritonitis was due to touch contamination.As of (b)(6) 2016, the patient's signs and symptoms of peritonitis have resolved, and the patient continued continuous cycler-assisted peritoneal dialysis (ccpd) therapy with the cycler without further issue.

Manufacturer Narrative

Medical records did not contain dialysis treatment records or hospital/dialysis progress notes for review.Medical records did not mention a source for the patient¿s peritonitis.Physician notes revealed the patient had a history of medical non-compliance.In addition, the patient¿s comorbidities ((b)(6) and history of steroid use) would negatively impact the patient¿s immunity from infection.There was no documentation in the medical records that indicated a causal relationship between the liberty cycler and patient¿s events.The device was not returned to the manufacturer for physical evaluation and the failure mode can not be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.In addition, the device history review confirmed the labeling, material, and process controls were within specification.

Event Description

Medical records were received from the patient's treatment facility.The patient presented to the hospital on (b)(6) 2016 with abdominal pain, generalized weakness and a low grade fever.The patient was admitted and diagnosed with staphylococcus epidermidis peritonitis.Patient was treated with antibiotics.In addition, the patient was also treated with antibiotics for right lower lobe pneumonia.Patient was also diagnosed with a urinary tract infection with pyuria.Patient improved and was discharged home on (b)(6) 2016 and arrangements were made for outpatient antibiotic administration.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer (Section G): CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5488879
• MDR Text Key: 39975151
• Report Number: 2937457-2016-00244
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Other Device ID Number: 00840861100972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2010
• 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: 91 YR
• Patient Weight: 68