BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11762982 · Received May 3, 2021

    Report

    Report Number
    2016493-2021-505114
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    March 19, 2021
    Report Date
    April 19, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    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. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 18MAR2013. 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.

    Description of Event or Problem · 0

    CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATED, "AN IV LINE WAS BEING REMOVED FROM A CAREFUSION 303, INC. ALARIS PUMP. IT WAS NOTED THAT THE IV LINE WOULD NOT SELF-CLAMP TO THE PUMP, ALTHOUGH THE IV LINE WAS STILL CONNECTED TO THE PATIENT. PITOCIN BOLUSED FOR APPROXIMATELY 5 SECONDS. ACCORDING TO THE CLMICAL/BIOMEDICAL TEAM, WHEN THE OPERATOR FORCES THE LATCH TO CLOSE, IT CAN BREAK THE IV CLAMP AND MAY AFFECT PROPER INFUSING. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : CLEAR AIR FROM IV LINE. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) ; DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO;" THE BIOMED STATED : "THIS IS A CONCERN WITH THE CAREFUSION PUMP LATCH,WHEN THE OPERATOR FORCES THE LATCH TO CLOSE, IT CAN BREAK THE IV CLAMP AND MAY AFFECT PROPER INFUSING."

    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. DEVICE NOT RETURNED TO BD.

    Description of Event or Problem · 1

    CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATED, "AN IV LINE WAS BEING REMOVED FROM A CAREFUSION 303, INC. ALARIS PUMP. IT WAS NOTED THAT THE IV LINE WOULD NOT SELF-CLAMP TO THE PUMP, ALTHOUGH THE IV LINE WAS STILL CONNECTED TO THE PATIENT. PITOCIN BOLUSED FOR APPROXIMATELY 5 SECONDS. ACCORDING TO THE CLINICAL/BIOMEDICAL TEAM, WHEN THE OPERATOR FORCES THE LATCH TO CLOSE, IT CAN BREAK THE IV CLAMP AND MAY AFFECT PROPER INFUSING. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : CLEAR AIR FROM IV LINE. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) ; DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO;". THE BIOMED STATED : "THIS IS A CONCERN WITH THE CAREFUSION PUMP LATCH, WHEN THE OPERATOR FORCES THE LATCH TO CLOSE, IT CAN BREAK THE IV CLAMP AND MAY AFFECT PROPER INFUSING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659624 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR 8015.| PRI TUBING.| 8015| PRI TUBING