BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 10931710 · Received December 2, 2020

    Report

    Report Number
    2016493-2020-54254
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Report Date
    November 5, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2909-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G3: AWARENESS DATE FIELD UPDATED TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING OVER THE PHONE TO DETERMINE THE CUSTOMER REPORTED ISSUE OF CUSTOMER REPORTS KEYS BEING INACTIVE ON THEIR 8015 KEYPAD. TECHNICAL SUPPORT RESOLUTION KEYPAD: 1. CUSTOMER WOULD LIKE TO ORDER A KEYPAD UNDER THE RECALL. 2. VERIFIED AFFECTED. 3. PROVIDED KEYPAD PART NUMBER AND EXPLAINED HOW THE ORDERING PROCESS WORKS WITH THE RECALL. 4. ORDER MANAGEMENT WAS UNAVAILABLE DUE TO MEETING. 6. PROVIDED ORDER MANAGEMENTS CONTACT INFO. 7. CUSTOMER WILL CALL TOMORROW. 8. ENDED CALL. SERIAL NUMBER WAS NOT PROVIDED THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED. BASED ON THE TROUBLESHOOTING RESULTS, TECHNICAL SUPPORT DETERMINED THE PROXIMATE CAUSE OF THE CUSTOMER¿S REPORTED ISSUE. TECHNICAL SUPPORT RESOLUTION THERE ARE CAPA #'S NOTED FOR THE FOLLOWING PARTS REPLACED THAT HAVE AN ALREADY EXISTING CAPA. UNRESPONSIVE KEYS / 1120033 THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED.

    Additional Manufacturer Narrative · 0

    G3: AWARENESS DATE FIELD UPDATED TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING OVER THE PHONE TO DETERMINE THE CUSTOMER REPORTED ISSUE OF CUSTOMER REPORTS KEYS BEING INACTIVE ON THEIR 8015 KEYPAD. TECHNICAL SUPPORT RESOLUTION KEYPAD: 1. CUSTOMER WOULD LIKE TO ORDER A KEYPAD UNDER THE RECALL. 2. VERIFIED AFFECTED. 3. PROVIDED KEYPAD PART NUMBER AND EXPLAINED HOW THE ORDERING PROCESS WORKS WITH THE RECALL. 4. ORDER MANAGEMENT WAS UNAVAILABLE DUE TO MEETING. 6. PROVIDED ORDER MANAGEMENTS CONTACT INFO. 7. CUSTOMER WILL CALL TOMORROW. 8. ENDED CALL. SERIAL NUMBER WAS NOT PROVIDED THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED. BASED ON THE TROUBLESHOOTING RESULTS, TECHNICAL SUPPORT DETERMINED THE PROXIMATE CAUSE OF THE CUSTOMER¿S REPORTED ISSUE. TECHNICAL SUPPORT RESOLUTION THERE ARE CAPA #'S NOTED FOR THE FOLLOWING PARTS REPLACED THAT HAVE AN ALREADY EXISTING CAPA. UNRESPONSIVE KEYS / 1120033. THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. H3 OTHER TEXT : NO PRODUCT RETURNED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE HAS INACTIVE KEYS ON THE KEYPAD. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE HAS INACTIVE KEYS ON THE KEYPAD. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE HAS INACTIVE KEYS ON THE KEYPAD. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401561 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown