BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA NEPH 630 SYSTEM

    MDR report key: 10993897 · Received December 11, 2020

    Report

    Report Number
    9610806-2020-00063
    Event Type
    Malfunction
    Date Received
    December 11, 2020
    Date of Event
    November 9, 2020
    Report Date
    December 11, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZW
    PMA / PMN Number
    K001647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER SUSPECTING A BROKEN/DEFECT DILUENT PUMP IN THE SYSTEM. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. QUALITY CONTROLS (QC) RECOVERED IN RANGE AT THE TIME OF THE EVENT. IT WAS FOUND THAT THE DILUENT PUMP OF THE CUSTOMER'S ATELLICA NEPH 630 SYSTEM SPORADICALLY STOPPED PUMPING LIQUID. ADDITIONALLY, CRYSTALLIZATION BUILT UP ON THE OUTSIDE OF THE DILUTION PUMP HEAD. THE DILUENT PUMP WAS REPLACED BY THE CSE. THE CAUSE OF THE EVENT WAS THE DEFECTIVE DILUENT PUMP. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. THE ATELLICA NEPH 630 SYSTEM WITH CATALOG NUMBER 11239861 DESCRIBED IS NOT MARKETED IN THE UNITED STATES (US) AND THE PMA/510(K) NUMBER IS FOR THE US SIMILAR SYSTEM (BN PROSPEC SYSTEM). THE BN PROSPEC SYSTEM MARKETED IN THE US HAS CATALOG NUMBER 10461865 AND ITS UNIQUE DEVICE IDENTIFIER IS (B)(4).

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED KAPPA LIGHT CHAINS, LAMBDA LIGHT CHAINS, AND ALBUMIN RESULTS WERE OBTAINED ON FIVE CEREBROSPINAL FLUID (CSF) PATIENT SAMPLES FROM FOUR DIFFERENT PATIENTS ON AN ATELLICA NEPH 630 SYSTEM. IT IS UNKNOWN IF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, THE SAMPLES WERE REPEATED FOR KAPPA LIGHT CHAINS, LAMBDA LIGHT CHAINS, AND ALBUMIN, RESPECTIVELY, ALL OF WHICH RECOVERED LOWER. THE LOWER REPEAT RESULTS WERE CONSIDERED TO BE THE CORRECT RESULTS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED KAPPA LIGHT CHAINS, LAMBDA LIGHT CHAINS, AND ALBUMIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455568 ATELLICA NEPH 630 SYSTEM ATELLICA NEPH 630 SYSTEM JZW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH ATELLICA NEPH 630 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1