BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2991762 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05455
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K123874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT SENT IN FOR EVALUATION. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. THE CUSTOMER REPORTED CONDITION WAS NOT CONFIRMED; A ROOT CAUSE COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE NURSE WHO CAME INTO DIRECT CONTACT WITH THE CHEMOTHERAPY DRUG WAS NOT WEARING GLOVES AND WAS EXPOSED ON HER HAND. THE NURSE REPORTED FEELING LIGHTHEADED AND NAUSEATED. THE NURSE WENT TO THE EMERGENCY ROOM TO BE ASSESSED AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. THE CLINICAL NURSE SPECIALIST STATED THE NURSE HAS BEEN RETRAINED ON PROPER PROTECTIVE WEAR DURING ADMINISTRATION OF CHEMOTHERAPY DRUGS. THIS IS REPORT 1 OF 4 (SAME PRODUCT AS (B)(4)).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK BURETROL ADD-ON SET BROKE DURING INFUSION ON A PATIENT. THE NURSE CLAMPED OFF BOTH ABOVE AND BELOW THE BURETTE. REALIZING HER MISTAKE, SHE THEN OPENED UP THE VENT, CAUSING A SUDDEN RELEASE OF BUILT-UP PRESSURE, RESULTING IN THE BURETTE CRACKING AND APPROXIMATELY 35 CC'S OF AN UNKNOWN CHEMOTHERAPY DRUG TO LEAK OUT. THE NURSE, WHO WAS NOT WEARING GLOVES, WAS EXPOSED TO THE DRUG. THE NURSE WENT TO THE ER FOR ASSESSMENT BUT DID NOT REQUIRE ANY MEDICAL INTERVENTION. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95852 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 CHEMOTHERAPY