BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIMAG BLOOD PUMP

    MDR report key: 19531882 · Received June 13, 2024

    Report

    Report Number
    2916596-2024-03509
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 22, 2024
    Report Date
    March 6, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DWG
    UDI-DI
    07640135140634
    PMA / PMN Number
    K090051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION D4 (PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER): CORRECTION SECTION D5: CORRECTION SECTION H6 (MEDICAL DEVICE PROBLEM CODE): CORRECTION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE RETURNED PUMP CONFIRMED PLAY OF THE PUMP IN A TEST MOTOR; HOWEVER, THE PLAY WAS NEITHER UNUSUAL NOR LARGER IN COMPARISON TO A REFERENCE PEDIMAG PUMP AND IS EXPECTED BY DESIGN OF THE PRODUCT. IT WAS REPORTED THAT NO PATIENT WAS INVOLVED IN THE EVENT AS THE TEAM WET PRIMES CIRCUITS PRIOR TO USE AND HOLDS THE CIRCUIT IN STORAGE ON STANDBY. THE PEDIMAG BLOOD PUMP, LOT #1011810, WAS RETURNED WITH SHORT SECTIONS OF TUBING CONNECTED TO THE INLET AND OUTLET PORTS. VISUAL INSPECTION OF THE PUMP SHOWED NO EVIDENCE OF DAMAGE. THE PUMP WAS FORWARDED TO ABBOTT¿S ZURICH FACILITY FOR ADDITIONAL ANALYSIS. THE PUMP WAS INSERTED IN TWO TEST MOTORS WITHOUT ANY ISSUE. OF NOTE, THE MOTOR IN USE AT THE TIME OF THE REPORTED EVENT WAS NOT RETURNED FOR EVALUATION. WHEN THE LOCKING SCREW WAS FULLY EXTENDED, THE PUMP EXHIBITED PLAY IN BOTH TEST MOTORS. THE MAGNITUDE OF THE PLAY WAS NEITHER UNUSUAL NOR LARGER IN COMPARISON TO A REFERENCE PUMP, AND THE OBSERVED PLAY WAS NOT IMPAIRING THE PERFORMANCE OF THE PUMP. IT WAS NOTED THAT THE RETURNED PUMP WAS PRODUCED WITH NEW MOULDING TOOLS, AND IN COURSE OF THAT TOOL CHANGE, THE DIMENSION (THICKNESS) OF THE PUMP WAS SLIGHTLY REDUCED. THEREFORE, THIS PUMP HAS A LARGER PLAY BY DESIGN IN COMPARISON WITH HISTORIC PUMPS WHICH MAY CONTRIBUTE TO THE REPORTED FEELING OF LOOSENESS BY THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORD FOR THE CENTRIMAG BLOOD PUMP, LOT #10118106 / L08271-LB5, REVEALED NO RELEVANT DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE PEDIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE AND CONTAINS THE FOLLOWING ADDITIONAL WARNINGS AND CAUTIONS: IFU WARNING #12: FREQUENT PATIENT AND DEVICE MONITORING IS RECOMMENDED. IFU CAUTION #2: THIS DEVICE SHOULD ONLY BE USED BY PERSONS THOROUGHLY TRAINED IN EXTRACORPOREAL CIRCULATION PROCEDURES. IFU CAUTION #8: ENSURE THE BLOOD PUMP IS PROPERLY LOCKED INTO THE CENTRIMAG MOTOR. IFU CAUTION #15: ALWAYS HAVE A SPARE BLOOD PUMP, BACK-UP CONSOLE, MOTOR, AND ACCESSORIES AVAILABLE FOR CHANGE OUT. THE SECTION TITLED ¿BLOOD PUMP SETUP AND OPERATION¿ PROVIDES INSTRUCTIONS FOR HOW TO MOUNT THE BLOOD PUMP ON THE MOTOR. THE FOLLOWING INSTRUCTIONS ARE PROVIDED: TO MOUNT THE BLOOD PUMP ON THE CENTRIMAG MOTOR, REMOVE THE BLOOD PUMP FROM THE INNER TRAY AND INSERT THE BLOOD PUMP INTO THE MOTOR RECEPTACLE. PLACE THE BOTTOM OF THE BLOOD PUMP INTO THE MOTOR RECEPTACLE WITH THE OUTLET PORT POSITIONED IN THE LARGE GROOVE. MATCH THE GROOVES ON THE PERIPHERY OF THE BLOOD PUMP WITH THE FITTINGS ON THE MOTOR RECEPTACLE. ROTATE THE BLOOD PUMP COUNTERCLOCKWISE UNTIL THE BLOOD PUMP LOCKS SECURELY INTO PLACE. THREAD THE RETAINING SCREW CLOCKWISE TO SECURE IN PLACE. THE BLOOD PUMP MUST BE FULLY SEATED INTO THE RECEPTACLE TO FUNCTION PROPERLY. THE SECTION TITLED ¿PRE-BYPASS CHECKLIST¿ WARNS TO CHECK THE BLOOD PUMP FOR IRREGULAR MOTION AND NOISE DURING PRIMING. THE SECTION TITLED ¿EMERGENCY BACK-UP EQUIPMENT¿ STATES THAT A STERILE BACK-UP BLOOD PUMP CIRCUIT AND PRIMING ACCESSORIES MUST BE AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TEAM WET PRIMED THE CIRCUITS PRIOR TO USE. WHEN INSERTING THE PEDIMAG PUMP INTO THE MOTOR, THE PUMP HEAD REMAINED LOOSE AND MOVEABLE DESPITE THE MOTOR LOCKING SCREW INSERTED CORRECTLY. THE TEAM ATTEMPTED THE SAME PROCESS ON THE BACKUP MOTOR AND HAD THE SAME RESULT. THE TEAM DID NOT TRUST USING THE MOTOR AND WANTED A REPLACEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TEAM WET PRIMED CIRCUITS HELD IN STORAGE ON STANDBY PRIOR TO USE. WHEN THE PEDIMAG PUMP WAS INSERTED INTO THE CENTRIMAG MOTOR, THE PUMP HEAD REMAINED LOOSE AND MOVEABLE DESPITE THE MOTOR LOCKING SCREW BEING INSERTED CORRECTLY. THAT PUMP WAS ATTEMPTED TO BE PLACED IN ANOTHER MOTOR AND THE SAME ISSUE OCCURRED. THE ORIGINAL MOTOR SEEMED TO WORK WELL WHEN A PRACTICE PUMP HEAD WAS PLACED IN THE MOTOR AND IT SEATED PERFECTLY SO THE CONCERN WAS ONLY WITH THE PUMP HEAD. THE PEDIMAG PUMP WAS REPLACED IN THE WET CIRCUIT, WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938145 PEDIMAG BLOOD PUMP ELECTROSURGICAL DEVICE DWG THORATEC CORPORATION 201-90052 10118106 07640135140634

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown