BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURDIAL DX HEMODIALYSIS SYSTEM AND ACCESSORIES

    MDR report key: 14470001 · Received May 23, 2022

    Report

    Report Number
    3016250252-2022-00003
    Event Type
    Injury
    Date Received
    May 23, 2022
    Date of Event
    April 19, 2022
    Report Date
    June 6, 2022
    Manufacturer
    SHIBUYA (SBY)
    Product Code
    KDI
    UDI-DI
    00383790008815
    PMA / PMN Number
    K182940
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SERIAL NUMBER REPORTED IN INITIAL SUBMISSION WAS INCORRECT. REVISED SECTION D4 TO REFLECT THE CORRECT MACHINE SERIAL NUMBER.

    Description of Event or Problem · 0

    58 MINUTES INTO A TWO-HOUR DIALYSIS TREATMENT THE AFFECTED PATIENT STARTED VOMITING AND SUBSEQUENTLY HAD A WITNESSED GRAND-MAL SEIZURE. THIS LASTED 1-2 MINUTES AND THEN SUBSIDED. THE TREATMENT WAS ENDED WITH A TOTAL OF 489 ML UF(ULTRAFILTRATION). EMS WAS DISPATCHED AND BY THE TIME THEY ARRIVED IN THE FACILITY THE PATIENT WAS FULLY CONSCIOUS AND RECOVERED FROM THE EVENT. THE NURSE NOTED THAT THERE WAS NO CHANGE IN VITAL SIGNS BEFORE THE EVENT, AND NO INDICATION TO HER THAT THERE WAS AN IMPENDING EVENT. THIS PATIENT IS AN ESTABLISHED DIALYSIS PATIENT WITH NO HISTORY OF SEIZURES. PER THE NURSE, AFTER THE EVENT THE PATIENTS BLOOD PRESSURE WAS SLIGHTLY ELEVATED, BUT WITHIN NORMAL RANGE. THE PATIENT WAS TAKEN TO THE HOSPITAL AND CLEARED TO RETURN BACK TO THE NURSING HOME THAT SAME DAY. THE PATIENT RECEIVED DIALYSIS TREATMENTS WEDNESDAY (B)(6) 2022, THURSDAY (B)(6) 2022 AND FRIDAY (B)(6) 2022 WITH NO ADVERSE EVENTS. (B)(6) 2022: RN SAID PATIENT DIALYZED WITH NO ISSUES. PATIENT HAD HISTORY OF STROKE BUT NO HISTORY OF SEIZURES. PER NURSE, NO MEDICATIONS WERE GIVEN DURING THE TREATMENT WHEN THE EVENT HAPPENED, AND NO NEW MEDICATION WAS STARTED. PATIENT HAS CVC BUT HAD AVF SURGERY (B)(6) 2022. VITAL SIGNS: PRE TX: BP = 103/48, PULSE = 90, TEMP = 97.5, RR = 20 START OF TX: BP = 137/67, P = 81 DURING THE EVENT: BP = 142/119, P = 81 POST TX: 175/76, P = 95, TEMP = 96.2, RR = 22 EDW: 100.5 KG. PT CAME WITH 100.8 KG BUT HAS BEEN LOSING WEIGHT AND THEY HAVE HAD TO CHANGE EDW FOR SEVERAL TIMES FOR OVER A MONTH. NURSE INFORMED THE TEAM THAT PATIENT HAD BEEN LOSING WEIGHT AND IS ON DIETARY EVALUATION. OTHER DEVICES USED DURING EVENT:: NIPRO ELISIO 15H: DD+ELISIO-15H - LOT # 21J14F NIPRO BLOOD TUBING SET: BL+A430/V912, LOT# 20F15 CITRIC ACID: AC -200 - NURSE WAS NOT SURE WHAT WAS THE LOT # USED DURING THE TREATMENT. FOLLOWING LOT #S IN THE UNIT: N2B009, N2B007 AND N1H007.

    Description of Event or Problem · 0

    58 MINUTES INTO A TWO-HOUR DIALYSIS TREATMENT THE AFFECTED PATIENT STARTED VOMITING AND SUBSEQUENTLY HAD A WITNESSED GRAND-MAL SEIZURE. THIS LASTED 1-2 MINUTES AND THEN SUBSIDED. THE TREATMENT WAS ENDED WITH A TOTAL OF 489 ML UF(ULTRAFILTRATION). EMS WAS DISPATCHED AND BY THE TIME THEY ARRIVED IN THE FACILITY THE PATIENT WAS FULLY CONSCIOUS AND RECOVERED FROM THE EVENT. THE NURSE NOTED THAT THERE WAS NO CHANGE IN VITAL SIGNS BEFORE THE EVENT, AND NO INDICATION TO HER THAT THERE WAS AN IMPENDING EVENT. THIS PATIENT IS AN ESTABLISHED DIALYSIS PATIENT WITH NO HISTORY OF SEIZURES. PER THE NURSE, AFTER THE EVENT THE PATIENTS BLOOD PRESSURE WAS SLIGHTLY ELEVATED, BUT WITHIN NORMAL RANGE. THE PATIENT WAS TAKEN TO THE HOSPITAL AND CLEARED TO RETURN BACK TO THE NURSING HOME THAT SAME DAY. THE PATIENT RECEIVED DIALYSIS TREATMENTS (B)(6) WITH NO ADVERSE EVENTS. (B)(6) 2022: RN SAID PATIENT DIALYZED WITH NO ISSUES. PATIENT HAD HISTORY OF STROKE BUT NO HISTORY OF SEIZURES. PER NURSE, NO MEDICATIONS WERE GIVEN DURING THE TREATMENT WHEN THE EVENT HAPPENED, AND NO NEW MEDICATION WAS STARTED. PATIENT HAS CVC BUT HAD AVF SURGERY (B)(6) 2022. VITAL SIGNS: PRE TX: BP = 103/48, PULSE = 90, TEMP = 97.5, RR = 20 START OF TX: BP = 137/67, P = 81 DURING THE EVENT: BP = 142/119, P = 81 POST TX: 175/76, P = 95, TEMP = 96.2, RR = 22 EDW: 100.5 KG. PT CAME WITH 100.8 KG BUT HAS BEEN LOSING WEIGHT AND THEY HAVE HAD TO CHANGE EDW FOR SEVERAL TIMES FOR OVER A MONTH. NURSE INFORMED THE TEAM THAT PATIENT HAD BEEN LOSING WEIGHT AND IS ON DIETARY EVALUATION. OTHER DEVICES USED DURING EVENT:: NIPRO ELISIO 15H: DD+ELISIO-15H - LOT # 21J14F NIPRO BLOOD TUBING SET: BL+A430/V912, LOT# 20F15 CITRIC ACID: AC -200 - NURSE WAS NOT SURE WHAT WAS THE LOT # USED DURING THE TREATMENT. FOLLOWING LOT #S IN THE UNIT: N2B009, N2B007 AND N1H007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765142 SURDIAL DX HEMODIALYSIS SYSTEM AND ACCESSORIES HEMODIALYSIS MACHINE KDI SHIBUYA (SBY) MC+SDX01 00383790008815

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization