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U.S. Department of Health and Human Services

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

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FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER Back to Search Results
Device Problems Improper or Incorrect Procedure or Method; Appropriate Term/Code Not Available
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.

 
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Brand NameLIBERTY 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 Key4612051
Report Number2937457-2015-00355
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation
Type of Report Initial
Report Date 02/16/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/17/2015
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 Manufacturer03/03/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/17/2015 Patient Sequence Number: 1
Treatment
LIBERTY CYCLER SET,
FRESENIUS PD SOLUTION
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