BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGULAR PUMP SET 5000 - XL

    MDR report key: 2063177 · Received March 22, 2011

    Report

    Report Number
    9615050-2011-00175
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 22, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THIS REPORT REPRESENTS ALL OF THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    REPORT 1 OF 2. THE CUSTOMER CONTACT REPORTED A LEAK OF A CHEMOTHERAPEUTIC AGENT. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF THREE UNSPECIFIED CHEMOTHERAPEUTIC AGENTS. IT WAS REPORTED THAT THE TUBING SET AND THE CHEMOTHERAPEUTIC AGENTS WERE PREPARED BY THE PHARMACIST, PACKAGED AND GIVEN TO THE NURSE. AFTER RECEIPT OF THE PACKAGE, THE NURSE NOTED LIQUID IN THE PACKAGING AND THE PACKAGE WAS RETURNED TO THE PHARMACIST. IT WAS REPORTED THAT FORTY MINUTES LATER, THE SAME TUBING SET AND THE CHEMOTHERAPEUTIC AGENTS WERE RETURNED TO THE NURSE. THE PHARMACIST INDICATED THAT THERE WAS NO LEAKAGE. THE CUSTOMER CONTACT REPORTED THAT AFTER THE DELIVERY WAS STARTED, THE NURSE NOTED LEAKAGE OF THE CHEMOTHERAPEUTIC AGENTS FROM AN UNSPECIFIED Y-SITE OF THE TUBING SET. THE DELIVERY WAS STOPPED AND THE PHARMACIST WAS CONTACTED. THE SOLUTION THAT SPILLED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL FOR THIS PATIENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REGULAR PUMP SET 5000 - XL 80FRN FRN HOSPIRA COSTA RICA LTD. NA 712155H

    Patients

    Seq Age Sex Outcome Treatment
    1