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

Model Number LIB

Device Problem Insufficient Information (3190)

Patient Problem Peritonitis (2252)

Event Date 07/06/2011

Event Type  Injury  

Event Description

A peritoneal dialysis pt called fresenius tech support due to drain problems, pt line and drain complication alarms.The pt was unable to complete treatment and went to the hosp due to the inability to drain.During follow up it was learned the pt also had peritonitis.

Manufacturer Narrative

A product investigation was performed for the device.The actual device was not returned for eval.A review of the device history record was performed.There was no unexpected variances, adjustments or comments noted in the device record.A review of the complaint history found no other complaints of the reported pl - pt line blocked warning and one other complaint of the reported dc - drain complication warning.A review was performed by the post market clinical dept.Per the parmacovigilance physician the (b)(6) yr old pt with esrd has had a history of peritonitis that predates the call to tech support on (b)(6) 2011.There was no reported cycler problems or (b)(6) 2011, revealed that the pt lived with 5 other people in the room.She had been performing dialysis treatment in the same room with these people and no one was wearing any masks.The pt was also not washing her hands while doing her treatments.This is a retrospective mdr being submitted by fresenius medical care as a remediation action committed to fda regarding all potential adverse events received between (b)(6) 2011 to (b)(6) 2013.

• Brand Name: FRESENIUS LIBERY CYCLER
• Type of Device: PERITONEAL DIALYSIS SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer Contact: tanya taft ; 920 winter st; waltham, MA 02451 ; 7816999751
• MDR Report Key: 4112633
• MDR Text Key: 19802837
• Report Number: 2937457-2014-02678
• 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
• Type of Report: Initial
• Report Date: 07/06/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• 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: RTLR180020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Weight: 48