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

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 02/16/2015

Event Type  Injury  

Event Description

A continous cycling peritoneal dialysis (ccpd) patient's registered nurse (rn) called technical support requesting a replacement cycler.She added the patent reported to her, he had multiple cycler alarms (sensor) which resulted in hospitalization due to under dialyzing.Upon follow up contact with the patient's peritoneal dialysis rn (pdrn), she stated the patient informed her that he was in the hospital due to under dialyzing.The pdrn reported the patient did not inform the pd staff of these continued cycler issues.Additionally, the patient was constantly manipulating his treatments (making them shorter or not dialyzing at all), stating that he knows better than the staff how his treatments should be completed.She does not believe that the cycler caused or contributed to this event but rather it was the culmination of the patient's non-compliance to his pd prescription.The patient continues with the ccpd program and medical records have been requested.

Manufacturer Narrative

(b)(4).Based on the information provided, it is unknown how the device may have caused or contributed to the event.The post market surveillance department requested the patient's medical records but they have not yet been provided.The actual device was returned to the manufacturer for physical evaluation.Visual inspection determined that the ground line on the front panel assembly was pierced by the front, left corner screw of the top cover.There were no other internal discrepancies.Further evaluation found no device malfunctions that would have caused the reported event.A batch record review was conducted and the device history record review indicated: production floor problem report - burn-in: m41 patient sensors too high, reject to rework (b)(6) 2011, rework: no problem found, return to burn-in (b)(6) 2011, burn-in passed (b)(6) 2011.There were no deviations or non-conformances during the manufacturing process.Product labeling, material, and process controls were within specifications.A supplemental medwatch report will be submitted upon review of the patient's medical records and clinical investigation.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; walnut creek CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: jerry succuro, ccht, ma ; 920 winter st; waltham, MA 02451-1457 ; 7816970376
• MDR Report Key: 4612051
• MDR Text Key: 5659841
• Report Number: 2937457-2015-00355
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/16/2015

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2009
• 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: LIBERTY CYCLER SET,; FRESENIUS PD SOLUTION
• Patient Outcome(s): Hospitalization; Life Threatening