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

Model Number LLIBERTY

Device Problems Filling Problem (1233); Restricted Flow rate (1248); Blocked Connection (2888)

Patient Problem Hypervolemia (2664)

Event Date 08/08/2015

Event Type  Injury  

Manufacturer Narrative

The device is being returned for evaluation but has not yet been made available.A medwatch follow-up will be submitted upon further evaluation.

Event Description

A peritoneal dialysis (pd) patient, reported that she was not able to drain fluid.During troubleshooting all of the lines and setup appeared to be correct.The patient and caregiver tried advancing to fill 1 and the cycler alarmed for a patient line blockage.A new setup resulted in the same issue.The patient reported feeling pain.They were advised to discontinue using the cycler and to contact the patient's pd nurse.During follow up, the patient's pd nurse reported the patient was hospitalized (b)(6) 2015 for fluid overload.Her home nurse had assessed her and suggested hospitalization.It is unknown what was causing the drain issues, however she has not been treated for peritonitis or had catheter manipulation reported to the clinic at this time.The patient remains hospitalized and it is believed that the fluid overload is related to a cardiac issue rather than pd.The patient was also undergoing care for wound healing following a surgery.The pd nurse does not have any medical notes for these events, yet as she heard this from the patient's daughter, and has not received any medical records from the hospital.Medical records are being requested.

Manufacturer Narrative

The actual device was returned to the manufacturer for physical evaluation.The system was visually inspected with no issues found.Two simulated treatments were performed using the received cycler, and there were no unexpected alarms or problems that occurred during testing.A simulated treatment was performed in which the amount of fluid delivered to a pseudo-patient bag during each fill phase was weighed.The weighed fluid volumes were compared against the programmed fill value, and the weighed volumes for each fill phase were determined to be within expected tolerance for the liberty cycler.The system's physical tests passed.There were no internal, visual discrepancies found in the inspection of the received cycler unit.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 manufacturing review confirmed the labeling, material, and process controls were within specification.Medical records were requested but no records have been received to date.

• 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: 5061780
• MDR Text Key: 25257599
• Report Number: 2937457-2015-01396
• 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: Followup
• Report Date: 08/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LLIBERTY
• Device Catalogue Number: RTLR180111
• Other Device ID Number: 00840861100972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2009
• 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: 65 YR
• Patient Weight: 62