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

Model Number LIB

Device Problem Insufficient Information (3190)

Patient Problem Peritonitis (2252)

Event Date 04/01/2015

Event Type  Injury  

Event Description

A peritoneal dialysis patient's spouse reported the patient was admitted to the hosp with a diagnosis of peritonitis.Exact date of hospitalization was not reported.

Manufacturer Narrative

This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of event.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 nonconformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

Manufacturer Narrative

Corrected device review: the device was returned to the manufacturer for evaluation.A visual inspection of the returned cycler showed no sign of any physical damage.The following tests were performed: simulated use testing, valve actuation test, and system air leak test.A visual internal inspection was performed and there were no discrepancies encountered during the internal visual inspection.A device history record review was performed and the device was found to have been manufactured per specifications.

Manufacturer Narrative

The system level review of the liberty cycler's concomitant products found no indication that the products caused or contributed in any way to the clinical event.Medical records were requested several times and not received.

• Brand Name: LIBERTY CYCLE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS USA, INC; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanyla taft, rn cnor ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4823583
• MDR Text Key: 5841019
• Report Number: 2937457-2015-01050
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2015

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
• Device Model Number: LIB
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2015
• Initial Date FDA Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD SOLUTION
• Patient Outcome(s): Hospitalization