BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCU MODULE

    MDR report key: 11272031 · Received February 3, 2021

    Report

    Report Number
    2016493-2021-16824
    Event Type
    Injury
    Date Received
    February 3, 2021
    Report Date
    January 15, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 01/29/2019. 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))6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN TRACKWISE AND SAP WAS PERFORMED FOR THE SN (B)(6) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER. THE ROOT CAUSE OF THE CUSTOMER¿S COMPLAINT OF DISPLAY ERROR 13-1033-149 COULD NOT BE CONFIRMED; NO PRODUCT OR DEVICE LOGS WERE RETURNED FOR INVESTIGATION THE REPORTED ISSUE THAT THE PUMP HAD A DISPLAY ERROR 13-1033-149 COULD NOT BE CONFIRMED; NO PRODUCT OR DEVICE LOGS WERE RETURNED FOR INVESTIGATION. NO FURTHER INVESTIGATION OF THIS EVENT IS POSSIBLE AT THIS TIME. THE DEVICE IS USED FOR TREATMENT PURPOSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INFUSION AN ERROR CAME UP ON THE 8100 DEVICE THAT DISPLAYED ERROR 13-1033-149 AND SHUT DOWN THE ALARIS SYSTEM. THE CUSTOMER REPORTED THE EVENT CAUSED HARM TO THE PATIENT, BUT DID NOT PROVIDE SPECIFIC INFORMATION ON HOW THE PATIENT WAS HARMED.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INFUSION AN ERROR CAME UP ON THE 8100 DEVICE THAT DISPLAYED ERROR 13-1033-149 AND SHUT DOWN THE ALARIS SYSTEM. THE CUSTOMER REPORTED THE EVENT CAUSED HARM TO THE PATIENT, BUT DID NOT PROVIDE SPECIFIC INFORMATION ON HOW THE PATIENT WAS HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172865 ALARIS PCU MODULE PCU, INFUSION FRN CAREFUSION SD 8015 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 8100| PRI TUBING,8015,THERAPY DATE UNKNOWN| PRIMARY TUBING| PRI TUBING,8015,THERAPY DATE UNKNOWN