BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE YSITE 104IN NDEHP

    MDR report key: 3823372 · Received March 20, 2014

    Report

    Report Number
    9615050-2014-02192
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    October 8, 2013
    Report Date
    February 20, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER OF THE DEVICE IN USE WAS UNKNOWN. ONE SEALED PRIMARY TUBING SET FROM LOT #370435H AND ONE SEALED SECONDARY TUBING SET WERE RECEIVED AND EVALUATED. THE DEVICES PASSED TESTING. NO LEAK OF SOLUTION WAS NOTED DURING THE TESTING PROCEDURES. BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK. THE PLUMSET WAS BEING USED TO DELIVER 250 ML NORMAL SALINE, AT AN UNSPECIFIED RATE, VIA A PLUM A+ PUMP. AT AN UNSPECIFIED TIME, THE NON-VENTED LOCKING CAP ON THE PORT OF THE CASSETTE OF THE PLUMSET WAS REMOVED AND THE OPTION-LOK MALE ADAPTER OF A SECONDARY TUBING SET WAS CONNECTED TO THE PORT OF THE CASSETTE FOR THE PIGGYBACK DELIVERY OF MAGNESIUM SULFATE 2 GM/250 ML, FOR A DURATION OF ONE HOUR. AFTER THE DELIVERY OF MAGNESIUM SULFATE WAS COMPLETED, THE SECONDARY TUBING SET WAS DISCONNECTED FROM THE PORT. AT THIS TIME, THE MALE ADAPTER OF AN UNSPECIFIED SECONDARY SET WAS CONNECTED TO THE PORT FOR THE PIGGYBACK DELIVERY OF IPILIMUMAB 1277.7 MG/255.54 ML. IT WAS REPORTED THAT TWO HOURS AFTER THE PRIMARY TUBING SET WAS PLACED INTO CLINICAL USE, THE PATIENT NOTED A SMALL PUDDLE OF SOLUTION NEAR THE BASE OF THE PUMP. THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM THE BOTTOM OF THE CASSETTE OF THE PLUMSET ONTO THE FLOOR. AT 1437, THE DELIVERY WAS STOPPED. THE CUSTOMER CONTACT INDICATED THAT THE PUMP INDICATED THAT A TOTAL VOLUME OF 77 ML HAD BEEN DELIVERED. THE PHYSICIAN WAS NOTIFIED AND ORDERED THE PATIENT TO RECEIVE THE REMAINING DOSE OF THE IPILMUMAB. NO SPECIFIC DETAILS WERE PROVIDED. IT WAS REPORTED THAT THE PHARMACY REMIXED THE MEDICATION. THE PLUMSET WAS REPLACED. AT 1621, THE DELIVERY OF IPILMUMAB WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167762 PLUMSET CLAVE YSITE 104IN NDEHP 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LIST # UNK, LOT #UNK| LIST #14230, LOT #UNK| UNSPECIFIED SECONDARY TUBING SET,| SECONDARY TUBING SET,