BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 10694471 · Received October 16, 2020

    Report

    Report Number
    2016493-2020-17972
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Report Date
    June 22, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K091308
    Removal / Correction Number
    Z-2910-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF NOT POWERING ON AND THE "CHARGE" LIGHT NOT WORKING WHEN THE DEVICE IS PLUGGED INTO AC POWER WAS NOT CONFIRMED ON ANY OF THE THREE RETURNED KEYPADS. RECEIVED THREE USED PN: TC10008389 - 8015 ALARIS PC UNIT FRONT CASE ASSEMBLIES. SERIAL NUMBERS AND KEYPAD LOT NUMBER: (B)(4) - 058505, (B)(4) - 058505, (B)(4) ¿ 060408. PHYSICAL INSPECTION OF THE THREE ASSEMBLIES WAS PERFORMED. THEY WERE FOUND TO BE BD APPROVED PARTS. NO DAMAGE WAS SEEN. INTERNAL INSPECTION WAS PERFORMED ON ALL RETURNED KEYPADS. EACH LAYER OF THE FRONT CASE WAS REMOVED AND INSPECTED FOR ANOMALIES. FLUID CONTAMINATION WAS OBSERVED ON ALL KEYPADS. A LOG ANALYSIS WAS NOT PERFORMED. THE CUSTOMER DID NOT RETURN THE SUSPECT DEVICE NOR LOGS FOR REVIEW; ONLY THE 8015 ALARIS PC UNIT FRONT CASE ASSEMBLIES WERE RETURNED FOR INVESTIGATION. SERIAL NUMBER (B)(4) - WHEN TESTED, THE PC UNIT WOULD TURN ON. ALL LED¿S FUNCTIONED EXCEPT THE WATCHDOG LED. ALL KEYS FUNCTIONED AS INTENDED. AFTER DISASSEMBLING THE KEYPAD, DRIED FLUID WAS SEEN ACROSS MULTIPLE TRACES. SERIAL NUMBER (B)(4) - WHEN TESTED, THE PC UNIT WOULD TURN ON. ALL LED¿S FUNCTIONED PROPERLY. ALL KEYS FUNCTIONED AS INTENDED. AFTER DISASSEMBLING THE KEYPAD, DRIED FLUID WAS SEEN ACROSS MULTIPLE TRACES. SERIAL NUMBER (B)(4) - WHEN TESTED, THE PC UNIT WOULD TURN ON. ALL LED¿S FUNCTIONED PROPERLY. ALL KEYS FUNCTIONED AS INTENDED. AFTER DISASSEMBLING THE KEYPAD, DRIED FLUID WAS SEEN ACROSS MULTIPLE TRACES. KEYPADS THAT PASS FUNCTIONALITY TESTING ARE TESTED THREE TIMES TO CHECK FOR INTERMITTENCY. AN EXTENSIVE INVESTIGATION FOR THIS ISSUE HAS BEEN PREVIOUSLY PERFORMED AND COMPLETED. PRIMARY ROOT CAUSES FOR KEYPAD FAILURES ARE INADEQUATE CLEANING PROCESSES AND DESIGN. THE UNRESPONSIVE PC UNIT KEYPADS OCCUR DUE TO CORROSION AND DAMAGE TO THE CIRCUIT LAYER WHEN FLUID INGRESSES TO THE BOTTOM RIGHT QUADRANT OF THE KEYPAD, WHERE THE FLEX CABLE BENDS TO THE BACKSIDE OF THE FRONT COVER. FLUID INGRESS CAUSES CRACKS IN THE FLEX CABLE SECTION OF THE KEYPAD AND CORROSION OF THE SILVER TRACES RESULTING IN TRACE INTERRUPTION IDENTIFIED AS AN OPEN OR SHORT CIRCUIT, ULTIMATELY LEADING TO UNRESPONSIVE KEYPAD KEYS. DEVICE HISTORY REVIEW: SERIAL NUMBER (B)(4) SERVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 11/13/2017. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE 09/21/2020. IT INDICATED THAT THIS DEVICE HAD NOT BEEN PREVIOUSLY RETURNED FOR SERVICE. A REVIEW OF THE PRODUCTION FAILURE RECORDS WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE THROUGH THE PRESENT. THE FAILURE RECORD SHOWED NO PRODUCTION FAILURE RECORDS WERE OPENED FOR THE SOURCE DEVICES. QN DATABASE P/N TC10008389: A QN DATABASE SEARCH WAS PERFORMED ON THE THREE RETURNED FRONT CASE WITH KEYPAD ASSEMBLIES P/N TC10008389. THERE ARE SEVEN QUALITY NOTIFICATIONS OPENED FOR P/N TC10008389; HOWEVER, THERE WERE NO QUALITY NOTIFICATIONS RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER IS REPLACING THE FRONT CASE DUE TO THE DEVICES NOT POWERING ON DUE TO A KEYPAD ISSUE. IN ADDITION, THE CUSTOMER HAS NOTED THAT SOMETIMES THE "CHARGE" LIGHT DOES NOT WORK WHEN THE DEVICE IS PLUGGED INTO AC POWER. (PCU)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155850 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1