BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREFLOW SL

    MDR report key: 1192420 · Received October 7, 2008

    Report

    Report Number
    3003464075-2008-00462
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 8, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KPO
    PMA / PMN Number
    K060296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DIALYSATE SACK WAS DISCARDED AND NOT AVAILABLE FOR EVAL BY NXSTAGE. THEREFORE, IT COULD NOT BE INSPECTED FOR DAMAGE. EXACT LOT NUMBER USED COULD NOT BE PROVIDED. TWO POSSIBLE LOT NUMBERS WERE PROVIDED. MFG QUALITY CONTROL RECORDS FOR BOTH LOTS WERE REVIEWED AND NO PROBLEMS WERE FOUND. NO SIMILAR PROBLEMS HAVE BEEN REPORTED WITH EITHER LOT REPORTED OR ANY OTHER LOTS. THIS APPEARS TO BE A RANDOM, ISOLATED EVENT. EXACT CAUSE IS UNK BUT IS MOST LIKELY USER CONTAMINATION SINCE NO OTHER EVENTS HAVE BEEN REPORTED. DEVICE LABELING CONTAINS APPROPRIATE INSTRUCTIONS AND WARNINGS REGARDING THE USE OF ASEPTIC TECHNIQUE WHEN HANDLING DISPOSABLE CONNECTIONS. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED

    Description of Event or Problem · 1

    APPROX ONE HOUR INTO A ROUTINE HEMODIALYSIS TREATMENT, PT DEVELOPED CHILLS, 102.5 F FEVER, AND HAD A PANIC ATTACK. TREATMENT WAS DISCONTINUED AND PT TRANSPORTED TO ER. PT ADMITTED TO RULE OUT SEPSIS. BLOOD CULTURES WERE NEGATIVE. CLINIC NURSE OBTAINED SAMPLES USING STERILE TECHNIQUE FROM THE WATER PURIFICATION PACK AND THE DIALYSATE SACK FOR CULTURE AND LAL TESTING. PT RECEIVED TWO DOSES OF ANTIBIOTICS LEVAQUIN AND DAPTOMYCIN, POTASSIUM DUE TO LOW BLOOD POTASSIUM LEVEL, AND EPOGEN DUE TO DECREASE IN HEMOGLOBIN. PT WAS DISCHARGED IN 2008 WITH NO FURTHER MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUREFLOW SL DIALYSATE CONCENTRATE FOR HEMODIALYSIS KPO NXSTAGE MEDICAL, INC. SAK-001 FG-080528-51

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other