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

Catalog Number RTLR180111

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Congestive Heart Failure (1783); Uremia (2188); Peritonitis (2252); Hypervolemia (2664)

Event Date 09/21/2015

Event Type  Injury  

Manufacturer Narrative

The post market surveillance staff is in the process of requesting medical records applicable to the event.A supplemental medwatch report will be submitted when further info is received.

Event Description

A peritoneal dialysis (pd) patient's registered nurse (rn) stated the patient was hospitalized on (b)(6) 2015 for congestive heart failure and fluid overload following several days of missed treatments and as a result of non-compliance w/his peritoneal dialysis treatments.Per pd rn, the pt had reportedly been experiencing drain issues for several days and stated although the pt was trained on performing stat drains as well as manual peritoneal dialysis therapy.The pt discontinued treatments and did not revert to continuous ambulatory peritoneal dialysis (capd) treatments and initially did not contact her or technical services for assistance when the issues occurred.The nurse stated a perma-catheter was sited and the pt has since switched modalities to completing hemodialysis treatments which began (b)(6) 2015.Per pdrn, the patient's peritoneal dialysis catheter was scheduled for removal on (b)(6) 2015.Per pdrn, as of (b)(6) 2015, the patient was still hospitalized and was expected to continue completing hemodialysis treatments while hospitalized and upon discharge.Medical records were requested.

Manufacturer Narrative

The 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-conformances during the manufacturing process.In addition, the device record review confirmed the labeling, material, and process controls were within specification.Medical records were reviewed by post market surveillance staff.Based on the 21 pages of medical records information it appears on (b)(6) 2015 the patient presented to an emergency department with recent peritonitis and was admitted to the hospital with complaints of nausea, decreased oral intake, cachexia, and severe weakness.The patient's admitting diagnoses were uremia due to failed pd therapy, severe malnutrition, hypertension, controlled off meds, and anemia of chronic kidney disease.On (b)(6) 2015, the patient had no abdominal pains and the pd effluent was clear with culture results being negative.Medical records revealed that the patient was not able to perform her pd treatments at home due to not practicing hand hygiene and aseptic technique.On (b)(6) 2015, the patient's treatment modality was changed from peritoneal dialysis to hemodialysis, the patient was dialyzed, and was transfused with blood products.On (b)(6) 2015, the patient's status improved and she was discharged home, with the need to be retrained on pd therapy.Peritoneal dialysis (pd) patients with end stage chronic renal failure have a high prevalence of heart failure at the beginning of the pd therapy, and the risk of developing heart failure, new or recurring, during the course of pd treatment is close to 40%-60% (reference clin j am soc nephrol 2011;6:805-812).At the time of this review, there is no clinical information that could allow us to analyze an as an association between the congestive heart failure and the peritoneal dialysis process.The received medical records did not contain information regarding the alleged event of congestive heart failure and fluid overload.

Event Description

Medical records were provided by the patient's dialysis center.The peritoneal dialysis (pd) patient was hospitalized on (b)(6) 2015 due to congestive heart failure and fluid overload.The hospital admission was due to congestive heart failure and was caused by non-compliance with their renal replacement therapy.

Event Description

During review of the peritoneal dialysis (pd) patient's medical records it was apply discovered the patient had reportedly been diagnosed with an episode of peritonitis.Follow-up was made with the pd patient's clinic registered nurse (rn) regarding the peritonitis event documented in the medical records received on 09/29/2015.Per pdrn the patient had been diagnosed with an episode of peritonitis while hospitalized on (b)(6) 2015.The nurse indicated the episode of peritonitis was likely due to touch contamination, where the patient was known to not practice aseptic technique during peritoneal dialysis treatments.The nurse indicated several cultures were performed while the patient was hospitalized but no growth was observed.No additional medical records or information was available regarding the peritonitis event.

• 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 ; 7816999000
• MDR Report Key: 5117821
• MDR Text Key: 27345661
• Report Number: 2937457-2015-01464
• Device Sequence Number: 1
• Product Code: FKX
• 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,other,use
• Reporter Occupation: Nurse
• Type of Report: Followup,Followup
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2010
• 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
• Patient Age: 71 YR
• Patient Weight: 59