BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFICATION TO: STOCKERT S5 SYSTEM

    MDR report key: 1666945 · Received April 19, 2010

    Report

    Report Number
    1718850-2010-00023
    Event Type
    Malfunction
    Date Received
    April 19, 2010
    Date of Event
    November 24, 2009
    Report Date
    December 3, 2009
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE PUMP IS A COMPONENT OF THE S5 SYSTEM. THE 510(K) NUMBER IS K071318. PLEASE NOTE THAT THIS MDR IS BEING FILED LATE DUE TO A RECENT CHANGE IN SORIN GROUP (B)(4) MEDWATCH REPORTING CRITERIA AND SUBSEQUENT REVIEW OF PAST COMPLAINTS TO THE NEW CRITERIA. THE INCIDENT OCCURRED AT THE HOSPITAL (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE INCIDENT WAS INVESTIGATED BY THE FIELD SERVICE ENGINEER. DAMAGE WAS NOTED ON THE PUMP PANEL LOCATED BETWEEN THE OVERRIDE KEYS. THE SPEED KNOB WAS ALSO DAMAGED. AFTER DISMOUNTING THE PANEL, SPACERS HOLDING THE BOARD THAT ALLOWS THE OVERRIDE KEYS TO FUNCTION WERE FOUND BROKEN. THE PUMP WAS SENT TO SORIN GROUP (B)(4) FOR FURTHER ANALYSIS. VISUAL INSPECTION REVEALED THE FOLLOWING MECHANICAL DAMAGES: THERE WERE NOTCHES AND SCRATCHES AT THE PUMP CONTROL PANEL, THE CONTROL PANEL IN THE RANGE OF THE SPEED SENSOR WAS BENT, THE BAR GRAPH AT THE SPEED SENSOR WAS STRIPPED, AND THE OVERRIDE BUTTONS COULD NOT BE ACTIVATED MANUALLY. DISASSEMBLY OF THE PUMP REVEALED THAT THE SPACERS HOLDING THE CONTROLS HAD DAMAGE AND THERE WAS A PRESENCE OF FLUID THAT HAD PENETRATED THIS AREA. THE CONTROL PANEL WAS CHANGED OUT AND SUBJECTED TO TESTING. THE PUMP WAS TESTED FOR 48 HOURS. NO ERRORS WERE FOUND. SORIN GROUP (B)(4) STATED THAT THE PUMP WAS RETURNED IN POOR CONDITION. THE PUMP SHOWED MECHANICAL DAMAGES, WHICH APPEARED TO BE THE RESULT OF SOME EXTERNAL FORCE. AS A RESULT OF THE DAMAGE, THE OVERRIDE BUTTONS COULD NOT BE ACTIVATED. THE CAUSE OF THIS DAMAGE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE BUBBLE SENSOR ALARMED. THE PERFUSIONIST TRIED TO OVERRIDE THE ALARM WITHOUT SUCCESS. THE PUMP WAS POWER CYCLED WITH NO RESULTS. THE PERFUSIONIST HAND CRANKED THE PUMP TO MAINTAIN BLOOD FLOW. AFTER THE PROCEDURE, THE PERFUSIONIST WAS NOT SURE THAT THE OVERRIDE KEY WAS PUSHED AND THEN HELD LONG ENOUGH TO CORRECTLY DISABLE THE ALARM. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODIFICATION TO: STOCKERT S5 SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1