BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 12075396 · Received June 28, 2021

    Report

    Report Number
    2016493-2021-508643
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Report Date
    July 17, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF INOPERABLE KEYPADS WAS CONFIRMED ON 15 PUMP MODULES THROUGH TESTING DURING THE INVESTIGATION. ¿ ASM¿S KEYPAD TASK WAS UTILIZED TO PERFORM KEYPAD TESTS ON EACH KEYPAD OBSERVING ALL KEYS FAILING ON ALL CUSTOMER UNITS. ¿ RESULTS FROM A REVIEW OF THE SERVICE HISTORY RECORDS SHOWED EVERY RETURNED DEVICE MANUFACTURED IN 2017, INDICATING THAT EACH UNIT HAS A PRINTEC DOOR ASSEMBLY WITH KEYPAD. O ACCORDING TO DRA (B)(4) (PRINTEC LVP UNRESPONSIVE KEYS), CUSTOMER DEVICES ARE WITHIN THE AFFECTED POPULATION OF 01 DEC 2016 TO PRESENT. O DRA (B)(4) WAS PREVIOUS OPENED AS A RESULTS OF THE FAILURE MODE ASSOCIATED WITH UNRESPONSIVE PRINTEC KEYPADS WHICH ALSO RELATES TO THIS COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 15MAR2017. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN BD2 TRACKWISE WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE KEYPADS ARE INOPERABLE.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF INOPERABLE KEYPADS WAS CONFIRMED ON 15 PUMP MODULES THROUGH TESTING DURING THE INVESTIGATION. ASM¿S KEYPAD TASK WAS UTILIZED TO PERFORM KEYPAD TESTS ON EACH KEYPAD OBSERVING ALL KEYS FAILING ON ALL CUSTOMER UNITS. RESULTS FROM A REVIEW OF THE SERVICE HISTORY RECORDS SHOWED EVERY RETURNED DEVICE MANUFACTURED IN 2017, INDICATING THAT EACH UNIT HAS A PRINTEC DOOR ASSEMBLY WITH KEYPAD. ACCORDING TO DRA (B)(4) (PRINTEC LVP UNRESPONSIVE KEYS), CUSTOMER DEVICES ARE WITHIN THE AFFECTED POPULATION OF 01 DEC 2016 TO PRESENT. DRA (B)(4) WAS PREVIOUS OPENED AS A RESULTS OF THE FAILURE MODE ASSOCIATED WITH UNRESPONSIVE PRINTEC KEYPADS WHICH ALSO RELATES TO THIS COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 15MAR2017. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(4) WAS PERFORMED IN BD2 TRACKWISE WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE KEYPADS ARE INOPERABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970660 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown