BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10072166 · Received May 19, 2020

    Report

    Report Number
    2016493-2020-01071
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Date of Event
    February 4, 2020
    Report Date
    April 23, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G.3, G.3(OTHER SOURCE) DEVICE HISTORY: REVIEW OF THE SN (B)(6) SERVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 01/19/2018. 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 NOT BEEN PREVIOUSLY RETURNED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A BOTTLE SIDE PRESSURE SENSOR ERROR CODE 240.4150. THERE WAS NO PATIENT HARM REPORTED. THE ISSUE OCCURRED AT (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A BOTTLE SIDE PRESSURE SENSOR ERROR CODE 240.4150. THERE WAS NO PATIENT HARM REPORTED. THE ISSUE OCCURRED AT (B)(6) ON UNIT MKY-PELS.

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED. BECAUSE NO DEVICE OR DEVICE LOGS WERE RETURNED OR EXPECTED TO BE RETURNED, NO FAILURE INVESTIGATION COULD BE PERFORMED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT IDENTIFIED. NO PATIENT INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A BOTTLE SIDE PRESSURE SENSOR ERROR CODE 240.4150. THERE WAS NO PATIENT HARM REPORTED. THE ISSUE OCCURRED AT (B)(6) HOSPITAL ON UNIT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535847 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 (1) PRI TUBING| 8015, THERAPY DATE (B)(6)2020| 8015, THERAPY DATE (B)(6) 2020