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U.S. Department of Health and Human Services

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

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FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS LIBERTY CYCLER Back to Search Results
Model Number LIB
Device Problem Failure to Cycle
Event Date 03/18/2012
Event Type  Injury  
Event Description

A peritoneal dialysis patient called fresenius technical support regarding an m-21-10 invalid sensor reading in drain 0 of treatment. The patient was connected and had drained 71/50 mls on the cycler. The patient said he was expecting to drain about 2200 mls due to a manual fill earlier in the day. The patient stated he just got out of the hospital this afternoon. According to the patient the hospital visit is due to a combination of heart and dialysis issues. The patient rebooted the cycler but was unable to resume treatment. The patient is unable to re-set up the cycler because he does not have any extra 1. 5 percent dextrose bags which are what the doctor advised him to use tonight. Technical support replaced the cycler.

 
Manufacturer Narrative

A product investigation was performed for this device. A visual inspection showed no physical exterior discrepancies. The reported m21-10 symptom was confirmed due to worn pump motor. A review of the device history record was performed. There were no unexpected variances, adjustments or comments noted in the device record. A review of the complaint or comments noted in the device record. A review of the complaint tracking system listed no other complaints of this symptom for this device. A review was performed by the post market clinical department. Per the pharmacovigilance physician, the event of hypovolemic and cardiogenic shock is unlikely related to the liberty cycler machine. The patient has a history of severe cardiac disease including hypertension. The event might have resulted from a dialysis prescription not adjusted to the patients current condition and also due to low blood pressure. The patient pd plan was adjusted adn his blood pressure medications have been put on hold. There was a problem reported on the cycler after hospitalization. The continuous cycle peritoneal dialysis.

 
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Brand NameFRESENIUS LIBERTY CYCLER
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
concord CA
Manufacturer (Section G)
FRESENIUS MEDICAL CARE NORTH AMERICA
4040 nelson ave.
concord CM 94520
Manufacturer Contact
tanya taft, rn cnor
920 winter st.
waltham , MA 02451-1457
7816999000
MDR Report Key4249704
Report Number2937457-2014-03093
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type Consumer
Type of Report Initial
Report Date 03/18/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/06/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberLIB
Device Catalogue NumberRTLR180020
Was Device Available For Evaluation? Yes
Date Manufacturer Received04/12/2012
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 TREATMENT DATA
Date Received: 11/06/2014 Patient Sequence Number: 1
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