BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACING/PSI KIT: 5FR/6 F R FR 2-L

    MDR report key: 2971713 · Received January 30, 2013

    Report

    Report Number
    1036844-2013-00039
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    November 17, 2012
    Report Date
    January 29, 2013
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LDF
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT, REPORTED FROM A (B)(6), OCCURRED DURING INSERTION. INDICATION FOR USE: PT UNSTABLE. WHEN THE PHYSICIAN ATTEMPTED TO INSERT A TRANSVENOUS PACEMAKER INTO THE PT, BLOOD WAS NOTED IN THE "BALLOON TUBING." THE PHYSICIAN IMMEDIATELY REMOVED THE PACEMAKER. A NEW PACEMAKER KIT WAS ACQUIRED AND INSERTED WITHOUT ISSUE. THE PHYSICIAN STATED THAT THERE HAS BEEN THE SAME PROBLEM WITH THE SAME PRODUCT AT ANOTHER HOSPITAL. THE USERS ARE CONCERNED AS THIS IS A POTENTIALLY LIFE THREATENING PROBLEM. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE THERAPY WAS DELAYED OR INTERRUPTED AND IT IS UNK IF IT CAUSED HARM TO THE PT. THE PT OUTCOME IS UNK. AN UPDATE RECEIVED ON (B)(6) 2013 FROM THE SALES REPRESENTATIVE STATED THERE WAS AN APPROXIMATE 10-15 MINUTE DELAY OR INTERRUPTION IN THERAPY WITH NO HARM TO THE PT. THE FIRST INSERTION SITE WAS THE JUGULAR AND THE SAME SITE (JUGULAR) WAS USED FOR THE SECOND INSERTION. THE PT OUTCOME WAS THE PT WAS ABLE TO BE TRANSFERRED TO THE CARDIAC CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41749 PACING/PSI KIT: 5FR/6 F R FR 2-L TEMPORARY PACING CATHETER PRODUCTS LDF ARROW INTERNATIONAL INC. RF1060444

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK