BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT-

    MDR report key: 10513054 · Received September 10, 2020

    Report

    Report Number
    2016493-2020-05170
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Report Date
    August 13, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K091308
    Removal / Correction Number
    Z-2909-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL CREATED TO REVISE H6 EVALUATION AND CONCLUSION CODES TO REFLECT NO FAULT FOUND.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE FRONT CASE WITH KEYPAD IS BEING REPLACED WITH RECALL REPLACEMENT PARTS. THE RETURNED FRONT CASE W/KEYPAD ASSEMBLIES WERE CONFIRMED NEW AND ARE LISTED IN THE MEDICAL DEVICE RECALL LETTER SENT TO THE CUSTOMER ON (B)(6) 2020. EXTERNAL INSPECTION WAS PERFORMED ON THE 7 PRINTEC (P/N TC10013702) KEYPADS DATE CODE 18/01 ((B)(6) 2018). THE KEYPADS WERE OBSERVED TO BE IN NEW UNUSED CONDITION WITH NO IRREGULARITIES OBSERVED. TEST RESULTS IDENTIFIED THE KEYPADS TESTED GOOD WITH NO FAULTS IDENTIFIED. TEST RESULTS: MAINTENANCE KEYPAD TEST: THE FRONT CASE KEYPAD (QTY 7 P/N TC10013702) WERE CONNECTED TO THE CAD PCU TEST FIXTURE #10013973 (EQ 111582) FOR FUNCTIONAL TESTING. THE KEYPAD¿S AC INDICATOR LIGHT ILLUMINATED AS EXPECTED AND ALL KEYS FUNCTIONED AS INTENDED. TEST METHOD INFORMATION: N/A N/A. THE RETURNED FRONT CASE W/KEYPADS ARE CONFIRMED NEW AND UNUSED. THE ASSEMBLIES WERE TESTED WITH NO IRREGULARITIES FOUND. THE ASSEMBLIES ARE BEING RETURNED PER RECALL FOR REPLACEMENT PARTS. REVIEW OF THE PCU MODULE 14355927 SERVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 04/01/2015. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE 10/28/2020 AND INDICATED THAT THIS DEVICE HAS NOT BEEN RETURNED TO SERVICE. REVIEW OF THE PRODUCTION FAILURE RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE THROUGH PRESENT. THE FAILURE RECORD SHOWED NO PRODUCTION FAILURE RECORDS WERE OPENED FOR THE SOURCE DEVICE. H3 OTHER TEXT : ONLY KEYPADS WERE RECEIVED FOR INVESTIGATION

    Description of Event or Problem · 0

    IT WAS REPORTED THE FRONT CASE WITH KEYPAD IS BEING REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE FRONT CASE WITH KEYPAD IS BEING REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE FRONT CASE WITH KEYPAD IS BEING REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979013 ALARIS PC UNIT- PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1