FREEDOM CYCLER PD+ PD+ IQCARD NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2003-02-27 for FREEDOM CYCLER PD+ PD+ IQCARD NA manufactured by Fresenius Medical Care - North America.

Event Text Entries

[286879] A home peritoneal dialysis patient reported that the cycler gave fill alarms and the solution bags were empty. The cycler data sheets showed incomplete treatments and drain volumes>4 liters. The patient's prescribed fill volume is 2,7000 ml. The patient also c/o of feeling bloated during these treatments. There was no serious injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2937457-2003-00006
MDR Report Key446018
Report Source04
Date Received2003-02-27
Date of Report2003-01-31
Date of Event2003-01-29
Report Date2003-01-31
Date Reported to Mfgr2003-01-31
Date Mfgr Received2003-01-31
Device Manufacturer Date2001-07-01
Date Added to Maude2003-03-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactELVY DIZON, BSN, RN, CNN
Manufacturer Street2637 SHADELANDS DR.
Manufacturer CityWALNUT CREEK CA 94598
Manufacturer CountryUS
Manufacturer Postal94598
Manufacturer Phone9252950200
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFREEDOM CYCLER PD+
Generic NamePERITONEAL DIALYSIS CYCLER
Product CodeKPF
Date Received2003-02-27
Returned To Mfg2003-02-10
Model NumberPD+ IQCARD
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Age1 YR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key434984
ManufacturerFRESENIUS MEDICAL CARE - NORTH AMERICA
Manufacturer Address2637 SHADELANDS DR. WALNUT CREEK CA 94598 US
Baseline Brand NameFREEDOM CYCLER PD+
Baseline Generic NamePERITONEAL DIALYSIS CYCLER
Baseline Model NoPD+ IQCARD
Baseline Catalog No180-60217
Baseline IDNONE
Baseline Device FamilyNA
Baseline Shelf Life ContainedN
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK915634
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2003-02-27

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