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

Model Number LIB

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problems Unspecified Infection (1930); Hypervolemia (2664)

Event Date 03/20/2012

Event Type  Injury  

Event Description

A peritoneal dialysis pt called fresenius tech support to report a system error alarm during setup, prior to treatment.The pt stated it was her first day back from being in the hosp for a month due to getting her catheter cleaned because she had not used it in a while and from pneumonia.During the call the pt noticed fluid leaking from the cap of the pt tubing line.The cassette compartment was also wet.During f/u activities the pt's peritoneal dialysis rn (pdrn) stated the pt was hospitalized from (b)(6) 2012 to (b)(6) 2012 for pneumonia.The pd catheter was not used during this hospitalization.The pt had not reported the cassette leak to her and there had been no episodes of infection since (b)(6) 2012, the date of the reported leak.The pdrn reviewed the pt's records and clarified the reason for the hosp admission.Chf, respiratory failure, dysfunctional catheter, and other issues - not pneumonia.The pt was given antibiotics for a bacterial infection of the catheter that resulted from touch contamination.Additionally, the pdrn reported the pt does not follow prescribed treatments and many times becomes fluid overloaded due to skipped and/or incomplete treatments, very non-compliant.Pt records provided to fmc indicate the pt was admitted to the hosp for pulmonary edema.

Manufacturer Narrative

A product complaint investigation was performed for this device.A visual inspection confirmed dried fluid within the cassette compartment.The reported alarm condition was confirmed.A batch record review was conducted and confirmed there were no deviations or non-conformances.Product labeling, material, and process controls were found to be within specifications.A search of complaint records listed no other fluid leaks or system error complaints for this device.The clinical investigation indicates the hospitalization for pulmonary edema occurred prior to the cassette fluid leak.Pt care records indicate the pt was given antibiotics for a pd catheter infection due to non-compliance of aseptic technique.The fmc pharmacovigilance physician concludes the event of pulmonary edema is unlikely related to the liberty cycler device.The complaint for the device malfunction post dated the hospitalization and could not have contributed to the event.The cycler device has been replaced and the pt continues on ccpd.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 LIBERTY CYCLER
• Type of Device: PERITONEAL DIALYSIS 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: 4059088
• MDR Text Key: 15181262
• Report Number: 2937457-2014-02214
• 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: 03/21/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIB
• Device Catalogue Number: RTLT180111
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/21/2012
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: CYCLER CASSETTE TUBING
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 33 YR
• Patient Weight: 112