BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 11579908 · Received March 27, 2021

    Report

    Report Number
    2916596-2021-01372
    Event Type
    Malfunction
    Date Received
    March 27, 2021
    Date of Event
    March 2, 2021
    Report Date
    June 15, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF NO EXTERNAL POWER ALARMS WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU) WAS CONFIRMED. THE SUBMITTED LOG FILE CONTAINED APPROXIMATELY 10 DAYS OF DATA ((B)(6) 2021 PER THE TIMESTAMP). THE LOG FILE CAPTURED NO EXTERNAL POWER ALARMS ON (B)(6) 2021 FROM 15:35:39 TO 15:35:49 AND FROM 15:37:18 TO 15:37:21 DUE TO THE VOLTAGE LEVELS ON BOTH POWER CABLES INSTANTLY DROPPING TO 0 V. THE ALARMS RESOLVED EACH TIME AS THE VOLTAGE LEVELS RETURNED TO THEIR APPROPRIATE VALUES. THE SYSTEM CONTROLLER BACKUP BATTERY PROVIDED POWER TO THE SYSTEM DURING THE LOSSES OF EXTERNAL POWER. NO OTHER NOTABLE ALARMS WERE ACTIVE IN THE LOG FILE. THE ALARMS DID NOT AFFECT THE CONTROLLER¿S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. THE MPU (SERIAL NUMBER: (B)(6)) WAS RETURNED TO SERVICE DEPOT FOR EVALUATION AND DAMAGE TO THE PATIENT CABLE WAS OBSERVED. THE MPU WAS FUNCTIONALLY TESTED WITH A TEST SYSTEM CONTROLLER AND MOCK CIRCULATORY LOOP AND THE REPORTED EVENT COULD NOT BE REPRODUCED; HOWEVER, AUDIBLE ALARMS FROM THE MPU WERE OBSERVED. THE MPU PATIENT CABLE WAS REPLACED AND THE ALARMS RESOLVED. THE CUSTOMER REQUESTED THAT THE MPU BE SCRAPPED. THE MPU WAS FORWARDED TO PRODUCT PERFORMANCE ENGINEERING (PPE) FOR FURTHER EVALUATION. PPE INSPECTION OF THE RETURNED MPU REVEALED SEVERAL KINKS ALONG THE LENGTH OF THE PATIENT CABLE. THE MPU WAS FUNCTIONALLY TESTED BY PPE WITH A TEST SYSTEM CONTROLLER AND MOCK CIRCULATORY. AUDIBLE ALARMS WITHOUT ANY VISUAL INDICATORS ON THE SYSTEM CONTROLLER OR MPU WERE OBSERVED. THE AUDIBLE ALARMS DID NOT AFFECT THE MPU¿S ABILITY TO PROVIDE POWER TO THE SYSTEM. THE MPU OPERATED THE SYSTEM ABOVE THE LOW SPEED LIMIT WITHOUT ISSUE, INCLUDING WHEN THE POWER CABLES WERE MANIPULATED BY HAND, AND THE REPORTED NO EXTERNAL POWER ALARMS COULD NOT BE REPRODUCED. FURTHER EVALUATION OF THE MPU REVEALED THAT THE ALARM SIGNAL WIRE WAS SHORTING TO THE CABLE SHIELDING; THIS CAUSED THE OBSERVED AUDIBLE ALARMS. THE OUTER JACKET WAS REMOVED FROM THE PATIENT CABLE, REVEALING DAMAGE TO THE UNDERLYING WIRES, SHIELDING, AND PROTECTIVE LAYERS. TEARS IN THE INSULATION OF BOTH OF THE REDUNDANT POWER WIRES, BOTH OF THE COMMUNICATION WIRES, THE ALARM SIGNAL WIRE, AND ONE OF THE REDUNDANT GROUND WIRES, RESULTING IN EXPOSED CONDUCTORS, WERE OBSERVED IN ADDITION TO BREAKDOWN OF THE CABLE SHIELDING AND PROTECTIVE LAYER; THIS WOULD ALLOW FOR THE POTENTIAL FOR AN ELECTRICAL SHORT TO OCCUR BETWEEN THE WIRES AND/OR THE CABLE SHIELDING. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS; HOWEVER, AN ELECTRICAL SHORT BETWEEN EITHER OF THE POWER WIRES AND THE CABLE SHIELDING, COMMUNICATION WIRES, OR REDUNDANT GROUND WIRE WOULD HAVE RESULTED IN THE REPORTED NO EXTERNAL POWER ALARMS. ALTHOUGH NOT CONCLUSIVELY DETERMINED, THE DAMAGE TO THE PATIENT CABLE AND UNDERLYING WIRES APPEARS CONSISTENT WITH REPETITIVE FLEXING OF THE CABLE DURING USE. HEARTMATE 3 PATIENT HANDBOOK (REV. C), UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C), UNDER SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING THE LOW VOLTAGE ADVISORY, POWER CABLE DISCONNECT, NO EXTERNAL POWER, AND BACKUP BATTERY FAULT ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. FURTHERMORE, THE SUBSECTION ¿WHAT NOT TO DO: DRIVELINE AND CABLES¿ INFORMS THE USER TO CHECK THE SYSTEM CONTROLLER AND MOBILE POWER UNIT (MPU) POWER CABLES FOR TWISTING, KINKING, OR BENDING WHICH COULD CAUSE DAMAGE TO THE WIRES INSIDE. THIS SECTION INFORMS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE SYSTEM CONTROLLER OR MPU POWER CABLES AND TO CAREFULLY UNRAVEL AND STRAIGHTEN THE CABLES IF THEY BECOME TWISTED, KINKED, OR BENT. HEARTMATE 3 PATIENT HANDBOOK (REV. C) AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C) UNDER SECTION 3 ¿POWERING THE SYSTEM¿, SUBSECTION ¿USING THE MOBILE POWER UNIT¿, EXPLAIN HOW TO USE THE MPU, INCLUDING HOW TO CONNECT THE AC POWER CORD TO THE MPU. THIS SECTION ALSO INFORMS THE USER TO TRANSFER FROM THE MPU TO ANOTHER POWER SOURCE IN THE EVENT OF A POWER FAILURE. DO NOT RELY ON THE CONTROLLER¿S BACKUP BATTERY AS A POWER SOURCE AS IT WILL ONLY POWER THE PUMP FOR A LIMITED AMOUNT OF TIME AND THE PUMP WILL STOP. SUBSECTION ¿SWITCHING POWER SOURCES¿ EXPLAINS HOW TO SWITCH FROM THE MPU TO BATTERIES. HEARTMATE 3 PATIENT HANDBOOK (REV. C) SECTION 6 "CARING FOR THE EQUIPMENT" AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C) SECTION 8 ¿EQUIPMENT STORAGE AND CARE¿ DESCRIBE HOW TO CARE FOR AND CLEAN ALL EQUIPMENT, INCLUDING THE MPU. HEARTMATE 3 PATIENT HANDBOOK (REV. C) SECTION 10 AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C) SECTION F, BOTH ENTITLED ¿SAFETY CHECKLISTS¿, PROVIDE CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE 3 LVAD, INCLUDING THE MPU. THESE SECTIONS ALSO INFORM THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. HEARTMATE 3 PATIENT HANDBOOK (REV. C) CAUTIONS USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THE MOBILE POWER UNIT, SERIAL NUMBER (B)(6), WAS SHIPPED TO THE CUSTOMER ON (B)(6) 2019. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: P060040; P160054.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS SLEEPING ON BATTERIES AS SHE IS GETTING NO EXTERNAL POWER DISCONNECTS ON MOBILE POWER UNIT. PATIENTS CONTROLLER AND MOBILE POWER UNIT WERE INSPECTED AND NO EXTERNAL WEAR/TEAR WAS NOTED. NO ALARMS OR ISSUES WERE NOTED WHILE ON BATTERY POWER. NO PARAMETER FLUCTUATIONS WERE NOTED AS WELL. THE PATIENT REPORTED THAT THE MOBILE POWER UNIT WOULD RANDOMLY SHUT OFF AND ALARM WHEN CONNECTED. THIS WAS DEMONSTRATED IN CLINIC ON (B)(6) 2021. LOG FILE ANALYSIS CAPTURED INSTANCES ON (B)(6) 2021 WHERE THE VOLTAGES INTERMITTENTLY DROPPED OUT. THIS CAUSED NO EXTERNAL POWER EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476007 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR