BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/4X3/16 NEONATAL PACK

    MDR report key: 4090102 · Received August 18, 2014

    Report

    Report Number
    2248146-2014-00379
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    August 22, 2013
    Report Date
    August 22, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFUSIONIST SHORTENED THE LENGTH OUTSIDE OF THE TRAY AND USED THE SUCKER LINE FOR THE CASE WITHOUT INCIDENT. THERE WAS NO IMPACT TO THE PT AS THIS WAS NOTICED BEFORE THE CASE BEGAN. THERE ARE FIVE MORE PACKS OF THIS LOT IN STOCK; HOWEVER, THE CUSTOMER HAS STATED THEY DO NOT WANT THEM TO BE PULLED BACK FOR INSPECTION. THE MFG SUPERVISOR WAS NOTIFIED OF THIS IN ORDER TO ENSURE PROPER PLACEMENT OF LINES DURING ASSEMBLY ON ALL FUTURE BUILDS OF THIS PACK. ALL MFG PERSONNEL HAVE BEEN RE-TRAINED ON THIS PARTICULAR PACK. THE DRAWING HAS ALSO BEEN MODIFIED TO BETTER ILLUSTRATE THE PLACEMENT OF THE SUCKER LINES IN ORDER TO FOOLPROOF ASSEMBLY OF THIS PACK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PACK BO-TOP 4112, LOT # 15533-06 WAS USED AND THE BLUE SUCKER LINE WAS PLACED IN THE STERILE TRAY BACKWARDS. THIS LED TO THE NON-STERILE "DESIGNED" PORTION TO BE ON THE INSIDE OF THE TRAY WHILE THE STERILE PORTION WAS ON THE OUTSIDE. THIS CAUSE THEREFORE HAD A GREAT DEAL OF TUBING TO BE ON THE FLOOR INSTEAD OF ON THE STERILE FIELD; ONLY A SMALL PORTION OF THIS LINE WAS ON THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496320 1/4X3/16 NEONATAL PACK CARDIOPULMONARY DEVICE DSP DATASCOPE CORP. BO-TOP 4112 15533-06

    Patients

    Seq Age Sex Outcome Treatment
    1