BEUDAMED
    FDA Adverse Event Other Summary report: N

    3 TO 1 REDUCTION DRIVE

    MDR report key: 2392327 · Received December 14, 2011

    Report

    Report Number
    1718850-2011-00151
    Event Type
    Other
    Date Received
    December 14, 2011
    Date of Event
    June 25, 2010
    Report Date
    August 26, 2011
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510(K) # IS K955038. SORIN GROUP (B)(4) MFR THE S3 ROLLER PUMP (510K NUMBER K950990) AND THE S3 DOUBLE HEADED ROLLER PUMP (510K NUMBER K955038). THE SPEED POTENTIOMETER IS A COMPONENT OF THESE PUMPS. THIS INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). PLEASE NOT THAT THIS MDR IS BEING FILED DUE TO A RECENT CHANGE IN SORIN GROUP (B)(4)'S MEDWATCH REPORTING CRITERIA AND SUBSEQUENT REVIEW OF PAST COMPLAINTS TO THE NEW CRITERIA. SORIN GROUP RECEIVED A REPORT THAT THE PUMP STOPPED AFTER A NEW SPEED POTENTIOMETER HAD BEEN INSTALLED. THERE WAS NO PT INJURY. THE SPEED POTENTIOMETER WAS SENT TO SORIN GROUP DEUTSCHLAND AND THEN TO THE SUPPLIER FOR FURTHER EVAL. THE SUPPLIER REPLIED THAT DURING TESTING THE PEED POTENTIOMETER FUNCTIONED PROPERLY. NO FAILURES WERE SEEN. THE REPORTED PROBLEM COULD NOT BE REPRODUCED. NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE PUMP STOPPED AFTER A NEW SPEED POTENTIOMETER HAD BEEN INSTALLED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 TO 1 REDUCTION DRIVE SPEED POTENTIOMETER DTQ SORIN GROUP DEUTSCHLAND 10-60-59 1001044

    Patients

    Seq Age Sex Outcome Treatment
    1