BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO AVF NEEDLE

    MDR report key: 4784831 · Received May 20, 2015

    Report

    Report Number
    8041145-2015-00033
    Event Type
    Injury
    Date Received
    May 20, 2015
    Date of Event
    January 20, 2014
    Report Date
    May 20, 2015
    Manufacturer
    NIPRO THAILAND CORPORATION LTD.
    Product Code
    FIE
    PMA / PMN Number
    K955182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE TWO LOT NUMBERS USED IN THIS EVENT VENOUS LOT: 13E17 ARTERIAL LOT: 13J12 THE DATES IN THIS REPORT FOR MANUFACTURE DATE AND EXPIRATION DATE ARE REFERRING TO THE VENOUS LOT OF 13E17. MANUFACTURE DATE AND EXPIRATION DATE FOR LOT 13J12 ARE PROVIDED BELOW MANUFACTURE DATE: 10/12/2013 EXPIRATION DATE: 09/30/2018.

    Description of Event or Problem · 1

    AN (B)(6) MALE PATIENT WAS TREATED WITH HEMODIALYSIS ON (B)(6) AT THE DIAVERUM MVZ REMSCHEID CLINIC IN (B)(6), USING AN AK200 S MACHINE, REVACLEAR 300 DIALYZER AND NIPRO AVF NEEDLES. THE PATIENT'S BLOOD PRESSURE PRIOR TO TREATMENT WAS 143/66 MMHG AND PULSE 85 BPM. APPROXIMATELY 1 HOUR AFTER START OF TREATMENT THE PATIENT RECEIVED NOVAMINSULFON DUE TO PAIN IN HIS KNEE WHICH HE HAD TWISTED ONE DAY EARLIER. AROUND 30 MINUTES LATER HE PRESENTED WITH SLIGHT HEADACHE, BLOOD PRESSURE INCREASE TO 180/62 MMHG AND TEMPERATURE OF 37.6 C. URISTIX AND URINE CULTURE WAS COLLECTED AND SENT FOR ANALYSIS. THE PATIENT WAS GIVEN METOCLOPRAMIDE IV AND THE TREATMENT WAS COMPLETED AS PLANNED. HOWEVER, THE PATIENT'S GENERAL CONDITION DETERIORATED AND HE WAS ADMITTED TO THE HOSPITAL. THE PATIENT HAD ALLEGEDLY BEEN ON MECHANICAL VENTILATION, BUT ON FEBRUARY 5 HE WAS CARDIOVASCULAR STABLE BUT STILL HOSPITALIZED. FURTHER MEDICAL, CLINICAL AND LABORATORY DATA HAS BEEN REQUESTED BUT ACCORDING TO THE CUSTOMER THIS DATA WILL ONLY BE AVAILABLE WHEN THE PATIENT IS DISCHARGED FROM THE HOSPITAL. NO DEFECTS WERE OBSERVED ON THE USED BICART, REVACLEAR 300, BLOOD LINES AND AV-FISTULA NEEDLE BEFORE OR AFTER THE EVENT. THE REVACLEAR WAS REPORTED TO BE CLEAN AFTER THE RINSE BACK PROCEDURE. BASED ON LABORATORY FINDINGS IT IS SUGGESTED THAT THE HOSPITALIZATION WAS RELATED TO THE PATIENT'S UNDERLYING MEDICAL CONDITION AND NOT RELATED TO DIALYSIS INDUCED HEMOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329724 NIPRO AVF NEEDLE FISTULA NEEDLE FIE NIPRO THAILAND CORPORATION LTD. 15G X 4/5" TC-15W GA 13E17 & 13J12

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization