BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO AVF NEEDLE

    MDR report key: 4784496 · Received May 20, 2015

    Report

    Report Number
    8041145-2015-00032
    Event Type
    Injury
    Date Received
    May 20, 2015
    Date of Event
    January 15, 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 LOTS OF NEEDLES INVOLVED IN THIS INCIDENT. VENOUS LOT: 13E17; ARTERIAL LOT: 13J12. INFORMATION IN THIS REPORT PROVIDED FOR MANUFACTURE DATE AND EXPIRATION DATE, RELATE TO THE VENOUS LOT OF 13E17. MANUFACTURE DATE AND EXPIRATION DATE FOR LOT 13J12 PROVIDED BELOW: MANUFACTURE DATE: 10/12/2013. EXPIRATION DATE: 09/30/2018. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING OUTPATIENT HEMODIALYSIS THERAPY ON (B)(6) 2014 AT THE DIAVERUM MVZ REMSCHEID CLINIC IN GERMANY USING AN AK200S AND REVACLEAR 400 DIALYZER AND NIPRO AVF NEEDLE. PATIENT WAS ASYMPTOMATIC BEFORE THE TREATMENT WITH BASELINE BLOOD PRESSURE OF 138/68 MMHG. FOUR HOURS INTO HIS TREATMENT THE BLOOD PRESSURE INCREASED TO 220/110 MMHG AND HE PRESENTED WITH NAUSEA AND VOMITING. SUBSEQUENT TO THAT, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH ABDOMINAL PAIN AND A TEMPERATURE OF 38.8 C. BLOOD SAMPLES UPON ADMISSION REVEALED A DROP IN HIS HEMOGLOBIN FROM BASELINE 11.9 G/DL TO 8.9 G/DL. HE HAD AN ELEVATED BILIRUBIN OF 8.9 G/DL. AN LDH >3200 U7L, A HAPTOGLOBIN LEVEL OF <0.2 AND POSITIVE SCHISTOCYTES IN PERIPHERAL SMEAR. HIS SERUM AMYLASE AND LIPASE WERE ELEVATED AS WELL AS HIS CRP. PATIENT WAS TREATED WITH CORTICOSTEROIDS, AND AN ANTIBIOTIC FOR PRESUMPTIVE DIAGNOSIS OF PNEUMONIA. THE PATIENT REMAINED IN THE HOSPITAL UNTIL (B)(6) 2014 WHEN HE WAS DISCHARGED HOME. DURING THE HOSPITALIZATION, HE REQUIRED 2 UNITS OF BLOOD TRANSFUSION. NO MACHINE MALFUNCTION WAS IDENTIFIED. NO DEFECTS WERE IDENTIFIED DURING MANUFACTURING FOR THE INVOLVED REVACLEAR 400 AND THE BICART AND NO SIMILAR EVENT WAS REPORTED. THERE IS SIGNIFICANT CLINICAL AND LABORATORY EVIDENCE SUGGESTING AN ACUTE HEMOLYTIC EVENT. ACUTE FEBRILE ILLNESS AND DIAGNOSIS OF PNEUMONIA SUGGEST A CLINICAL AND INFECTIOUS BASIS FOR THIS HEMOLYTIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329479 NIPRO AVF NEEDLE FISTULA NEEDLE FIE NIPRO THAILAND CORPORATION LTD. 15GX4/5" TC-15W GA 13E17 & 13J12

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R