BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEPHRETECT

    MDR report key: 233339 · Received July 23, 1999

    Report

    Report Number
    1221361-1999-00001
    Event Type
    Other
    Date Received
    July 23, 1999
    Date of Event
    July 19, 1999
    Report Date
    July 21, 1999
    Manufacturer
    ALDEN SCIENTIFIC, INC.
    Product Code
    HZT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DIALYSIS WAS TO BE PERFORMED PRIOR TO DIALYSIS, THE DIALYSATE WAS TESTED FOR FORMALDEHYDE, USING NEPHRETECT. THE TEST WAS PERFORMED ONCE, PER CLINIC PROCEDURE. THE RESULT WAS NEGATIVE AND DIALYSIS BEGAN. PATIENT IMMEDIATELY COMPLAINED OF DISCOMFORT, AND NUMBNESS IN EXTREMITIES. DIALYSIS WAS HAULTED AND THE DIALYSIS MACHINE WAS PROMPTLY REFRIGERATED. 07/20/99: DIALYSATE FROM THAT MACHINE WAS TESTED, AGAIN USING NEPHRETECT AND THE RESULTS WERE POSITIVE IN THREE OF THREE TRIALS. IT IS UNCLEAR AS TO THE TEMPERATURE OF THE DIALYSATE ANALYZED ON THIS DATE. 07/21/99: NURSE TELEPHONED ALDEN AND WAS ASKING IF THE TEMPRATURE OF THE DIALYSATE TESTED ON 07/20/99 COULD HAVE CAUSED THE TEST TO PRODUCE FALSE POSITIVE RESULTS ON THAT DAY. CO RESPONDED THAT A TEMPRATURE HIGHER THAN 37 DEGREES C CAN CAUSE FALSE POSITIVE RESULTS, BUT DID NOT OFFER ANY DATA CONCERNING SOLUTIONS BELOW 37 DEGREES C. SAMPLES OF THE DIALYSATE ARE UNAVAILABLE FOR ANALYSIS BY ALDEN. NORMAL TESTING DONE BY ALDEN ON THE NEPHRETECT LOT #09219 SHOWED IT MET ALL SPECIFICATIONS. CO TELEPHONED DIALYSIS CLINIC AND IN DISCUSSING THE INCIDENT WITH THE CLINICAL NURSE, IT IS BELIEVED THAT THE RISING PROCEDURE WAS NOT COMPLETELY FOLLOWED. CO DISCUSSED, IN DETAIL, THE CORRECT RISING PROCEDURE AND HAD SOME MINOR CHANGES MADE FOR THE CLINIC. THE CONCLUSION IS THAT IMPROPER RINSING PROCEDURES, PRIOR TO THE DEVICE USE, CAUSE THE DISINFECTANT(FORMALDEHYDE) "REBOUND SYNDROME".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPHRETECT FORMALDEHYDE DETECTOR HZT ALDEN SCIENTIFIC, INC. NA 09219

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other