MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIB; PERITIONEAL DELIVERY SYSTEM, AUTOMATED

Catalog Number LIB

Device Problem Human-Device Interface Problem (2949)

Patient Problem Congestive Heart Failure (1783)

Event Date 12/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A peritoneal dialysis (pd) registered nurse (rn) reported an (b)(6) male, end stage renal disease (esrd) patient, experienced fluid volume overload and was admitted to a hospital on an unknown date.The nurse stated the patient was not adequately dialyzing due to a wrong pd prescription, where the cycler was programmed incorrectly for 4 cycles and the nephrologist's prescription was written for 5 cycles.On an unknown date during the admission, the patient underwent a chest x-ray that showed fluid and congestive heart failure.No peritoneal dialysis treatments were missed and there was no reportable device malfunction.Relevant medical history included: congestive heart failure.As of (b)(6) 2015, the patient was discharged from the hospital, the episode of fluid volume overload has resolved.The patient's cycler's iq drive was reprogrammed with the correct prescription, and the patient continues to use continuous cycling peritoneal dialysis (ccpd) therapy without any further issues.

Manufacturer Narrative

Medical records received, reviewed, and clinical investigation completed.Corrected data: changed date from (b)(6) 2015.The actual device was not returned to the manufacturer for physical evaluation and the failure mode could not be confirmed.A batch record review was conducted and confirmed there were no deviation or non-conformances during the manufacturing process.Product labeling, material, and process controls were within specifications.There is no documentation in the medical record supporting a possible association between the liberty cycler and the event of fluid volume overload.However, there is a plausible association between the event of fluid volume overload, noncompliance to the prescribed pd therapy where 4 cycles was performed instead of 5 cycles, and inadequate dialysis associated with noncompliance.

• Brand Name: LIB
• Type of Device: PERITIONEAL DELIVERY SYSTEM, AUTOMATED
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson drive; concord CA 94520
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NA; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5363427
• MDR Text Key: 35797391
• Report Number: 2937457-2016-00041
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: LIB
• Device Lot Number: LC010463
• Other Device ID Number: 00840861100972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2011
• 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; Life Threatening
• Patient Age: 85 YR