BEUDAMED
    FDA Adverse Event Other Summary report: N

    MERCY HSP PITTSBURGH PA 1

    MDR report key: 2557702 · Received April 13, 2012

    Report

    Report Number
    1718850-2012-00034
    Event Type
    Other
    Date Received
    April 13, 2012
    Date of Event
    March 16, 2012
    Report Date
    March 16, 2012
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWE
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT. SORIN GROUP RECEIVED A REPORT THAT, DURING SETUP, THE PERFUSIONIST NOTICED THAT THE CUSTOMER PERFUSION PACK CONTAINED A 4:1 CARDIOPLEGIA SET INSTEAD OF AN 8:1 CARDIOPLEGIA SET. THE CARDIOPLEGIA SET WAS REPLACED WITH AN 8:1 CARDIOPLEGIA SET FROM THE SHELF PRIOR TO ANY PT INVOLVEMENT. A REVIEW OF INVENTORY FOUND THAT ONLY ONE LOT WAS BUILT UNDER THE INCORRECT SPEC AND ALL INVENTORY FROM THAT LOT WAS SENT TO THIS CUSTOMER. THE CUSTOMER HAS BEEN PROVIDED WITH REPLACEMENT CARDIOPLEGIA SETS TO REPLACE THE CARDIOPLEGIA SETS FOR ALL REMAINING AFFECTED PRODUCT. A REVIEW OF THE SPEC FOR THIS CUSTOM PERFUSION PACK FOUND THAT THE SPEC CALLED FOR THE INCORRECT CARDIOPLEGIA SET. FURTHER INVESTIGATION REVEALED THAT THIS WAS CAUSED BY AN ERROR ON THE PART OF THE INDIVIDUALS RESPONSIBLE FOR CREATING AND REVIEWING THE SPEC. IN ORDER TO PREVENT A RE-OCCURRENCE OF THIS ISSUE, THE INDIVIDUALS RESPONSIBLE FOR THE CREATION AND REVIEW OF THE SPEC HAVE BEEN RE-TRAINED. THIS IS AN ISOLATED EVENT OCCURRING AT ONLY THIS HOSP. NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT, DURING SETUP, THE PERFUSIONIST NOTICED THAT THE CUSTOM PERFUSION PACK CONTAINED A 4:1 CARDIOPLEGIA SET INSTEAD OF AN 8:1 CARDIOPLEGIA SET CALLED FOR IN THE SPEC. THE 4:1 CARDIOPLEGIA SET WAS REPLACED WITH 8:1 CARDIOPLEGIA SET FROM THE SHELF PRIOR TO ANY PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCY HSP PITTSBURGH PA 1 CUSTOM PERFUSION PACK DWE SORIN GROUP USA, INC. NA 1205500030

    Patients

    Seq Age Sex Outcome Treatment
    1