BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 SINGLE ROLLER PUMP

    MDR report key: 1669091 · Received April 23, 2010

    Report

    Report Number
    1718850-2010-00027
    Event Type
    Other
    Date Received
    April 23, 2010
    Report Date
    October 17, 2008
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B) (4) MANUFACTURES THE S5 ROLLER PUMP. THE 510(K) NUMBER IS K071318. THE INCIDENT OCCURRED AT HOPITAL (B) (6) IN (B) (6). THIS MEDWTCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B) (4). 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. AT THE START OF ECC, THE BUBBLE SENSOR ALARMED AND STOPPED THE ARTERIAL PUMP. THE CLINICIAN COULD NOT RESTART THE PUMP USING THE OVERRIDE KEYS ON THE SYSTEM PANEL OR PUMP PANEL. THE PUMP WAS RETURNED TO SORIN GROUP (B) (4) FOR EVAL. THE REPORTED PROBLEM COULD NOT BE REPRODUCED. SORIN GROUP (B) (4) CONCLUDED THAT THE KEYS ON THE SYSTEM PANEL AND THE PUMP PANEL WERE NOT PRESSED LONG ENOUGH TO OVERRIDE THE SYSTEM AND RESTART THE PUMP. SORIN GROUP (B) (4) COULD NOT RE-CREATE THE PROBLEM, NO DEFECT FOUND. THERE WAS NO REPORT OF PT INJURY. THE FACILITY FILED A VIGILANCE REPORT WITH THE (B) (6) AUTHORITY. THIS MEDWATCH REPORT IS FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    AT THE START OF ECC, THE BUBBLE SENSOR ALARMED AND STOPPED THE ARTERIAL PUMP. THE CLINICIAN COULD NOT RESTART THE PUMP USING THE OVERRIDE KEYS ON THE SYSTEM PANEL OR PUMP PANEL. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 SINGLE ROLLER PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE DWB SORIN GROUP DEUTSCHLAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1