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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
Catalog Number RTLR180111
Device Problems Device Alarm System (1012); Overfill (2404)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2015
Event Type  malfunction  
Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the device manufacturer's device evaluation.
 
Event Description
A continuous cycling peritoneal dialysis (ccpd) patient called technical support stating that he was receiving drain complication, drain line, and scale alarms.A review of the treatment data provided by the patient indicated a large drain 5: 4039ml.The patient felt no discomfort.Treatment data provided by the patient at time of call: drain 0: 818ml.Fill 1: 2203ml drain 1: 2956ml, fill 2: 2203ml drain 2: 2199ml, fill 3: 2203ml drain 3: 1597ml, fill 4: 2203ml drain 4: 1876ml, fill 5: 2203ml drain 5: 4039ml, fill 6: 1437ml no last drain.The reported drain volume of 4039ml was 184% over the expected drain volume which resulted in a reportable device malfunction.Upon follow up with the patient's pd nurse: she stated that she was aware of the drain issues and the large drain.The patient remained asymptomatic during and following the event.There was no serious injury or need for medical intervention.The patient did complete treatments manually while waiting for the replacement cycler.He didn't understand that "alternate" treatment meant manual exchanges, no treatments missed.The patient remains with the ccpd program in stable condition using the replacement cycler.
 
Manufacturer Narrative
The actual device was returned to the mfr for physical eval: a visual inspection of the returned cycler exterior showed no sign of physical damage.A simulated treatment (weighed vs.Programmed fill comparison) was performed and completed w/o any failures or problems.A simulated treatment was performed and completed w/o any failures or problems.The "as received" load cell value failed.The load cell "as received" value was out of specification, tared load cell.The load cell value and verification were within tolerance.The valve actuation test and system air leak test passed.The pt sensor calibration check passed.An internal inspection found visual evidence of dried fluid on the bottom cover between the pump assembly and display and within the recess of the bottom cover adjacent to the pump.The cause of the observed dried fluid could not be determined.Passed mushroom head check.A device manufacturing record review was conducted and confirmed there were no deviations or non-conformances during the manufacturing process.Product labeling, material, and process controls were within specifications.
 
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Brand Name
LIBERTY CYCLER
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
concord CA
Manufacturer (Section G)
CONCORD PLANT, FRESENIUS MEDICAL CARE NORTH AMERICA
4040 nelson ave
concord CA 94520
Manufacturer Contact
tanya taft, rn, cnor
920 winter street
waltham, MA 02451
7816999751
MDR Report Key5284947
MDR Text Key33230366
Report Number2937457-2015-01689
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
PMA/PMN Number
K043363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 12/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberRTLR180111
Other Device ID Number00840861100972
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/25/2015
Initial Date Manufacturer Received 11/08/2015
Initial Date FDA Received12/07/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/10/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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