BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREFLOW SL

    MDR report key: 1084835 · Received July 30, 2008

    Report

    Report Number
    3003464075-2008-00347
    Event Type
    Injury
    Date Received
    July 30, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 1, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KPO
    PMA / PMN Number
    K060296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO MANUFACTURING DEFECTS WERE FOUND UPON EXAMINATION OF THE RETURNED CARTRIDGE AND DIALYSATE SAK. QC RECORDS REVIEWED INDICATE PRODUCT WAS WITHIN SPECIFICATION. REVIEW OF THE SYSTEM LOG FILE INDICATES THAT THE DIALYSATE USED DURING THE TREATMENT WAS MOST LIKELY NOT THOROUGHLY MIXED DUE TO A RESTRICTION IN THE DIALYSATE SAK INLET LINE. THE LOG FILE INDICATES THAT THE DIALYSATE BATCH HAD BEEN PREPARED EARLIER THE SAME DAY OF THE TREATMENT AND FAILED THE CONDUCTIVITY CHECK, ALARMING TWICE BEFORE PASSING THE TEST ON THE THIRD ATTEMPT. THE LOG FILE FURTHER INDICATES THAT THE OPERATOR DID NOT MANUALLY MIX THE DIALYSATE BATCH FOLLOWING EACH CONDUCTIVITY CHECK FAILURE ALARM AS INSTRUCTED IN THE USER'S GUIDE. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED. THIS APPEARS TO BE A RANDOM ISOLATED EVENT. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    ABOUT 1.5 HOURS INTO A ROUTINE HEMODIALYSIS TREATMENT, PT REPORTED CRAMPS, NAUSEA, CHILLS, AND VOMITED. BLOOD PRESSURE AT THE START OF THE TREATMENT WAS 130/95, SYSTOLIC PRESSURE DROPPED INTO THE 90'S. PT WAS AFEBRILE. THREE LITERS OF NORMAL SALINE WAS ADMINISTERED BY THE CAREGIVER. TREATMENT WAS DISCONTINUED. FACILITY NURSE ADVISED CAREGIVER TO TRANSPORT PT TO THE ER. ABOUT AN HOUR LATER, THE PT CONTACTED THE FACILITY NURSE AND REPORTED THAT HE FELT MUCH BETTER AND NO LONGER WANTED TO GO TO THE HOSPITAL. PT WENT TO CLINIC FOR FURTHER ASSESSMENT AT NURSE'S REQUEST. BLOOD PRESSURE WAS 125/88 AND PT REPORTED CONTINUED NAUSEA, CHILLS AND VOMITED AGAIN. PT WAS ADMITTED TO HOSPITAL IN 2008. PT WAS ADMINISTERED, VANCOMYCIN, NEPSIN, AND SOLUMEDROL IV AND WAS DISCHARGED ON THE NEXT DAY, WITH DIAGNOSIS OF PYROGENIC REACTION. BLOOD CULTURES DRAWN UPON ADMISSION WERE NEGATIVE. LAL ENDOTOXIN TEST AND CULTURE OF DIALYSATE SAMPLE WERE NEGATIVE.

    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-0080416-51

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O