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

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

Patient Problem Uremia (2188)

Event Date 10/25/2015

Event Type  Injury  

Manufacturer Narrative

The patient's medical records were requested and had not been received at the time of this report.If the medical records should become available, a supplemental report will be submitted.A supplemental report will be submitted upon completion of plant's investigation.

Event Description

A peritoneal dialysis (pd) patient reported he was unable to complete treatment on the liberty cycler due to a visit to the emergency room.The patient stated it was not related to the cycler, and he was given a very strong medication that caused him to be disoriented and unable to setup for treatment.During a follow-up with the peritoneal dialysis registered nurse (pdrn), it was reported the patient was uremic and hospitalized.It was noted the patient missed a pd treatment.The pdrn stated the patient gets confused easily and gets frustrated.During an additional follow-up with the pdrn, it was noted the patient had transferred facilities.She could not provide additional information.

Manufacturer Narrative

The cycler was not replaced under this complaint.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 dhr review confirmed the 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 02451-1457 ; 7816999000
• MDR Report Key: 5254301
• MDR Text Key: 32344661
• Report Number: 2937457-2015-01652
• 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
• Type of Report: Initial,Followup
• Report Date: 11/24/2015

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?: No
• Device Operator: Lay User/Patient
• Other Device ID Number: 00840861100972
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2011
• 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
• Patient Age: 58 YR