FREEDOM CYPHER PD+ NEWTON IQ 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 2005-11-01 for FREEDOM CYPHER PD+ NEWTON IQ NA manufactured by Fresenius Medical Care North America.

Event Text Entries

[505520] The husband of a home peritoneal dialysis patient reported that the patient was overfilled during her ccpd treatment. She felt very uncomfortable and was short of breath when she woke up. She drained manually and was able to drain 2,800 ml. Her last fill was 1,000 ml. There was no serious injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2937457-2005-00016
MDR Report Key765312
Report Source04
Date Received2005-11-01
Date of Report2005-10-03
Date of Event2005-10-02
Report Date2005-10-03
Date Reported to Mfgr2005-10-03
Date Mfgr Received2005-10-03
Device Manufacturer Date2005-08-01
Date Added to Maude2006-09-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactELVY DIZON, BSN, RN, CNN
Manufacturer Street2637 SHADELANDS DRIVE
Manufacturer CityWALNUT CREEK CA 94598
Manufacturer CountryUS
Manufacturer Postal94598
Manufacturer Phone8002272572
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFREEDOM CYPHER PD+
Generic NamePERITONEAL DIALYSIS CYCLER
Product CodeKPF
Date Received2005-11-01
Returned To Mfg2005-10-24
Model NumberNEWTON IQ
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Age2 MO
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key753165
ManufacturerFRESENIUS MEDICAL CARE NORTH AMERICA
Manufacturer Address* WALNUT CREEK CA * US
Baseline Brand NameFREEDOM CYCLER PD+
Baseline Generic NamePERITONEAL DIALYSIS CYCLER
Baseline Model NoNEWTON IQ
Baseline Catalog No180-60300 (NEW)
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 2005-11-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.