BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM Y-BLOOD SET W/FLR CLAVE 110IN NDEHP

    MDR report key: 3970814 · Received April 29, 2014

    Report

    Report Number
    9615050-2014-03089
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    January 1, 2013
    Report Date
    January 10, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K103224
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK; SUBSEQUENTLY, IT WAS NOTED THAT THE PIERCING PIN OF THE TUBING SET HAD PUNCTURED THE BLOOD PRODUCT CONTAINER. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF AN UNSPECIFIED BLOOD PRODUCT , AT AN UNSPECIFIED RATE, VIA A PLUMA+ PUMP. THE CUSTOMER CONTACT REPORTED THAT THE BLOOD PRODUCT WAS PROBABLY PACKED RED BLOOD CELLS (PRBC'S). AT AN UNSPECIFIED TIME, THE PIERCING PIN OF THE TUBING SET WAS INSERTED INTO AN UNSPECIFIED ADMINISTRATION PORT OF THE BLOOD CONTAINER AND THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE NURSE NOTED THAT AN UNSPECIFIED VOLUME OF BLOOD HAD LEAKED ONTO THE PUMP. AT THIS TIME, THE SOURCE OF THE LEAK WAS NOT IDENTIFIED. IT WAS REPORTED THAT THE TUBING SET AND BLOOD CONTAINER WERE REPLACED AND THE THERAPY WAS RESUMED. NO SPECIFIC DETAILS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THAT THE BLOOD BANK RECORDS INDICATE THAT ON (B)(6) 2013, THE UNIT OF BLOOD WAS DESTROYED DUE TO THE BLOOD CONTAINER BEING PUNCTURED AND LEAKING INTO THE PUMP. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO CHANGE IN THE PT'S CONDITION. NO MEDICAL INTERVENTIONS WERE REPORTED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255775 PLUM Y-BLOOD SET W/FLR CLAVE 110IN NDEHP 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED BLOOD CONTAINER, MFR UNK| PLUM A+ SOFTWARE MODULE, LIST#20791, SN (B)(4)| PLUM A+ PUMP, LIST#20792, SN (B)(4)