BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PUMP

    MDR report key: 2062824 · Received April 11, 2011

    Report

    Report Number
    1718850-2011-00021
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP WHICH IS A COMPONENT OF THE S5 SYSTEM. THE 510(K) NUMBER FOR THE S5 SYSTEM IS K071318. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP USA RECEIVED A USER MEDWATCH ((B)(4)) WHICH STATED THE CARDIOPLEGIA PUMP WAS WORKING INTERMITTENTLY. AFTER HAND CRANKING, THE CARDIOPLEGIA DELIVERY SYSTEM WAS MOVED TO ANOTHER PUMP AND THE CASE WAS COMPLETED SUCCESSFULLY. THE USER MEDWATCH ALSO INDICATED THAT THE PUMP WAS TESTED BY THE FACILITY'S BIOMEDICAL ENGINEER WHO COULD NOT DUPLICATE THE PROBLEM EXCEPT WHEN HE OCCLUDED THE LINE. A SORIN GROUP REP WAS DISPATCHED TO EVALUATE THE PUMP. THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE MEDWATCH REPORT STATED THAT THE PUMP HAD BEEN REMOVED FOR EVAL BY THE SORIN REP. THE BIOMEDICAL ENGINEER WAS CONTACTED AND CONFIRMED THAT THE PUMP WAS NOT REMOVED FROM THE FACILITY BUT PLACED BACK INTO SERVICE AFTER BEING EVALUATED BY BOTH THE BIOMEDICAL ENGINEER AND THE SORIN REP. NO PROBLEMS WERE FOUND. THERE WAS NO REPORT OF PT INJURY. EVAL DONE BY THE FACILITY'S BIOMEDICAL ENGINEER AND THE SORIN GROUP USA REP SHOWED THAT THE PUMP PERFORMED TO SPEC. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 ROLLER PUMP HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ

    Patients

    Seq Age Sex Outcome Treatment
    1