BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11748356 · Received April 29, 2021

    Report

    Report Number
    2016493-2021-503816
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 15, 2021
    Report Date
    April 15, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H6, H10 A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF (B)(6) 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 FOR SN (B)(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 WAS PERFORMED FOR THE SN (B)(6) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A 24 HR. PARENTERAL NUTRITION INFUSION AT AN UNSPECIFIED RATE, IT WAS NOTED THAT THE INFUSION COMPLETED SOONER THAN EXPECTED. THE PHARMACY CONFIRMED THRU THE COMPOUNDING REPORT THAT THE CORRECT VOLUME AMOUNT WAS SENT. THE EVENT OCCURRED IN PICU, THERE WAS NO ADDITIONAL DETAILS OF PATIENT HARM OR CONSEQUENCES AT THIS TIME. OTHER UNSPECIFIED INFUSIONS AT THE TIME INCLUDED LVP, SYRINGE MODULE. THE CUSTOMER IS REQUESTING AN EVENT LOG REVIEW TO DETERMINE THE POSSIBLE CAUSE OF THE EVENT BETWEEN THE APPROXIMATE TIME FRAME OF 4/14 1900 - 4/15 1000.

    Additional Manufacturer Narrative · 1

    THE EVENT LOGS HAVE NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH EVALUATION RESULTS SHOULD THE LOGS BE RECEIVED FOR EVALUATION. CONT: SYRINGE UNKNOWN MANUFACTURER/SIZE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A 24 HR. PARENTERAL NUTRITION INFUSION AT AN UNSPECIFIED RATE, IT WAS NOTED THAT THE INFUSION COMPLETED SOONER THAN EXPECTED. THE PHARMACY CONFIRMED THRU THE COMPOUNDING REPORT THAT THE CORRECT VOLUME AMOUNT WAS SENT. THE EVENT OCCURRED IN PICU, THERE WAS NO ADDITIONAL DETAILS OF PATIENT HARM OR CONSEQUENCES AT THIS TIME. OTHER UNSPECIFIED INFUSIONS AT THE TIME INCLUDED LVP, SYRINGE MODULE. THE CUSTOMER IS REQUESTING AN EVENT LOG REVIEW TO DETERMINE THE POSSIBLE CAUSE OF THE EVENT BETWEEN THE APPROXIMATE TIME FRAME OF 4/14 1900 - 4/15 1000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641253 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 (2) PRI TUBING| 8015| 8100| 8110| CAD SYRINGE TUBE