BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM LC OL CNVRTBL P

    MDR report key: 1812328 · Received August 17, 2010

    Report

    Report Number
    9615050-2010-00153
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 23, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K865060
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS RETURNED TO THE CENTRAL SERVICES WITH A NOTE THAT STATED, "TUBE FELL APART. WAS NOT PULLED WHILE USING FOR KCL." THE NOTE ALSO INDICATED THAT THERE WAS DIFFICULTY IN CONTROLLING THE PT'S BLOOD PRESSURE. NO SPECIFIC EVENT DETAILS WERE PROVIDED; HOWEVER, IT WAS REPORTED THAT THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. IT WAS REPORTED THAT AFTER THE THERAPY WAS RESUMED AND THE PT'S BLOOD PRESSURE STABILIZED TO AN UNSPECIFIED LEVEL, THE CUSTOMER CONTACT INDICATED THAT THE PT IS FINE WITH ADVERSE OUTCOME, MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN SPECIFIC PT INFORMATION, THE PT'S BLOOD PRESSURE READINGS BEFORE AND AFTER THE TUBING SEPARATION, THE LOCATION OF THE TUBING SEPARATION AND HOW THE SEPARATION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM LC OL CNVRTBL P 80FRN FRN HOSPIRA COSTA RICA LTD. NA 890285H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention