BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 3.13 SINGLE C

    MDR report key: 2870059 · Received December 10, 2012

    Report

    Report Number
    9615050-2012-01494
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE HISTORY INDICATED ON (B)(6) 2012 AT 2314, CHANNEL A OF THE DEVICE WAS PROGRAMMED USING THE DRUG LIBRARY TO DELIVER DILTIAZEM 125 MG/125 ML, AT A RATE OF 10 ML/HR, WITH A TITRATED VTBI OF 120 ML, AND THE DELIVERY WAS STARTED. BETWEEN 1143 AND 1149, A PROXIMAL OCCLUSION ALARM OCCURRED, THE DELIVERY WAS STOPPED CASSETTE EJECTED, ALARM WAS CLEARED, STANDBY MODE ENTERED, CASSETTE EJECTED, CASSETTE LOADED, STANDBY MODE CANCELLED AND DELIVERY RESUMED. BETWEEN 1150 AND 1151, AN END OF INFUSION ALARM OCCURRED, CLEARED, KVO DELIVERY WAS STARTED AND STOPPED, A 115 ML TITRATED VTBI WAS PROGRAMMED AND THE DELIVERY WAS STARTED. BETWEEN 1328 AND 1418, 21 PROXIMAL OCCLUSION ALARMS OCCURRED AND WERE CLEARED. AT 1419, THE CASSETTE WAS EJECTED, A CHECK CASSETTE ALARM OCCURRED, CLEARED AND A CASSETTE WAS LOADED. BETWEEN 1502 AND 1532, 18 PROXIMAL OCCLUSION ALARMS OCCURRED AND WERE CLEARED. AT 1533, THE DELIVERY WAS STOPPED AND THE CASSETTE EJECTED. AT 1546, THE DEVICE WAS POWERED OFF. 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 DELAY IN CRITICAL THERAPY FOLLOWING AN ALARM CONDITION. AT AN UNSPECIFIED DATE AND TIME THE DEVICE WAS PROGRAMMED TO DELIVER DILTIAZEM 125 MG, AT A RATE OF 10 MG/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 115 ML, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE DEVICE ALARMED FOR PROXIMAL OCCLUSION. AT THAT TIME, THE NURSE TURNED THE DEVICE OFF AND ON TO CLEAR THE ALARM AND THE DELIVERY WAS RESUMED USING THE SAME DEVICE. BETWEEN 1143 AND 1547, THE NURSE REPORTED THE DEVICE ALARMED 39 TIMES FOR PROXIMAL OCCLUSION. THE NURSE TURNED THE DEVICE OFF AND ON EACH TIME TO CLEAR THE ALARM. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. ALTHOUGH THERE WAS POTENTIAL FOR SERIOUS INJURY, THE CUSTOMER CONTACT INDICATED THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ 3.13 SINGLE C 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 SYMBIQ TUBING SET: LIST #16068, LOT #UNK