BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11021270 · Received December 16, 2020

    Report

    Report Number
    2016493-2020-67617
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Report Date
    July 16, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2822-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE OF DIM SEGMENTS WAS CONFIRMED ON 9 OUT OF 10 RETURNED DISPLAY BOARDS. PHYSICAL INSPECTION NOTED EACH BOARD WAS PERFORMED AND NO DAMAGE, CORROSION, OR COLD SOLDER WAS OBSERVED. THE BOARDS WERE TESTED RUNNING BASIC INFUSIONS AT 888 ML/H AND 88.8 ML/H TO DETERMINE MISSING OR DIM SEGMENTS; DIM MEANING SOME LIGHT WAS VISIBLE, BUT NOT ENOUGH TO EASILY DETERMINE THE NUMBER THAT IS EXPECTED TO DISPLAY. TESTING RESULTS IDENTIFIED 9 OUT OF 10 RETURNED LVP DISPLAY BOARD ASSEMBLIES WITH DIM SEGMENTS. PCB S/N(B)(4) WAS OBSERVED WITH NO DIM SEGMENTS. THE EXACT ROOT CAUSE WAS NOT IDENTIFIED, HOWEVER PRIOR FAILURE INVESTIGATIONS IDENTIFIED THE MOST LIKELY PROBABLE CAUSE TO BE RELATED TO THE LED MANUFACTURING PROCESS AND/OR RAW MATERIALS. DEVICE HISTORY REVIEW: REVIEW OF THE S/N 4101879 SERVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 06/20/2004. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE (B)(6) 2020 AND INDICATED THAT THIS DEVICE HAS BEEN PREVIOUSLY RETURNED THREE TIMES FOR 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. ONLY DISPLAY BOARD WAS RECEIVED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD MISSING/BLANK DISPLAY SEGMENTS AND THE DISPLAY BOARD NEEDS TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485422 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1