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

Catalog Number 180111

Device Problems Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

Patient Problem Renal Disease, End Stage (2039)

Event Date 05/21/2012

Event Type  Injury  

Event Description

While delivering a replacement cycler, a (b)(6) driver was informed that the patient was in the hospital.Prior to hospitalization, the patient had rec'd numerous "m69 solution temperature high" alarms.The patient repeatedly bypassed the fill phase and went to dwell without receiving a fill.

Manufacturer Narrative

The liberty cycler was returned for evaluation; no non-conformities were found.Adjustments were made during simulated treatment testing to address loose mushroom heads.The alarm condition(s) alleged by the patient could not be confirmed.The fmc clinical investigation as reviewed by the physician states that user's problems with the device stem from user error and that "the assessment of her healthcare givers is that the patient's non compliance and poor understanding of the therapy lead to complications of underdialysis.Patient was assessed by the nursing staff as not a good candidate for pd/home therapy.There is no evidence of device malfunction".This is a retrospective mdr being submitted by fresenius medical care as a remediation action committed to fda regarding all potential adverse events rec'd between (b)(6) 2011 to (b)(6) 2013.

• Brand Name: FRESENIUS LIBERTY CYCLER
• Type of Device: PERITONEAL DIALYSIS CYCLER, FKX
• 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: 4060056
• MDR Text Key: 4807917
• Report Number: 2937457-2014-02020
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2012,05/21/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 180111
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/21/2012
• Date Manufacturer Received: 05/21/2012
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Weight: 109