BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLED RF PERISTALTIC PUMP CONNECTOR CABLE

    MDR report key: 3019390 · Received March 18, 2013

    Report

    Report Number
    9710452-2013-00003
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    January 24, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Product Code
    GEI
    PMA / PMN Number
    K031951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP CABLE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. EVAL IS IN PROGRESS; THEREFORE, THE ROOT CAUSE FOR THE REPORTED EVENT HAS NOT BEEN DETERMINED AT THIS TIME. IF ANY ADD'L RELEVANT INFO IS IDENTIFIED ONCE THE DEVICE IS EVALUATED, THE ADD'L RELEVANT INFO WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFO IS USED TO IDENTIFY THE NEED FOR ADD'L INVESTIGATION.

    Description of Event or Problem · 1

    FOLLOWING COMMENCEMENT OF PROCEDURE WITH THE PROBES ALREADY PLACED IN THE PT, PUMP MAPPING FAILED. UNSUCCESSFUL ATTEMPTS WERE MADE BY THE ATTENDING SALES REP TO CORRECT THE PROBLEM BY DISCONNECTING THE DEVICE, REBOOTING, AND CHANGING THE PROBES. THE CASE WAS ABORTED. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION REQUIRED. PLEASE NOTE THAT KIMBERLY-CLARK HEALTHCARE OWNS THIS PRODUCT LINE AND HAVE REPORTED AN MDR FOR THIS INCIDENT UNDER MFR REPORT NUMBER: 1033422-2013-00009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111954 COOLED RF PERISTALTIC PUMP CONNECTOR CABLE PUMP CONNECTOR CABLE GEI BAYLIS MEDICAL CO., INC. TDX-PMG-PPU

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR