MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS LIBERTY CYCLER; PERITONEAL DIALYSIS SYSTEM

Model Number LIB

Device Problem Invalid Sensing (2293)

Patient Problem Peritonitis (2252)

Event Date 10/22/2012

Event Type  Injury  

Event Description

A peritoneal dialysis rn called fresenius technical support.Pd rn states her pt called her (b)(6) 2012 and reported cloudy fluid, a fever, and pain in the abdomen.She stated the pt received his most recent cycler on (b)(6) 2012.The cause for the replacement was due to fluid leakage.The patient was connected to the cycler on (b)(6) 2012 was able to complete the treatment and did not have any problems.Rn is concerned that the cycler may have been the cause.The rn is following up to report the issue and requests we follow up with the pt.

Manufacturer Narrative

A product investigation was performed for this device.A visual inspection showed no physical exterior discrepancies.All functional tests passed.A simulated treatment was performed and completed with no issues or alarms.The reported symptoms were not confirmed.A review of the device history record was performed.There were no unexpected variances, adjustments or comments noted in the device record.A review of the complaint tracking system listed no other complaints for the reported symptom for this device.A review was performed by the post market clinical department.Per the pharmacovigilance physician, peritonitis is a known complication of peritoneal dialysis, usually caused by a break in the aseptic technique.E.Coili is part of normal flora and contamination may be caused by poor hand hygiene.There is no history of device malfunction which could have caused or contributed to the event of peritonitis.

• Brand Name: FRESENIUS LIBERTY CYCLER
• Type of Device: PERITONEAL DIALYSIS SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451 ; 7816999751
• MDR Report Key: 4283598
• MDR Text Key: 5228652
• Report Number: 2937457-2014-03250
• 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
• Report Date: 10/22/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIB
• Device Catalogue Number: RTLR80111
• Date Manufacturer Received: 10/22/2012
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PANTOPRAZOLE; GLUCOSAMINE; METROPOLOL TARTRATE; ALLOPURINOL; SENISPAR; RENVELA; GENTIMYCIN; CALCITROL; COUMADIN; BACTROBAN
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 78