BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 10667188 · Received October 12, 2020

    Report

    Report Number
    3007042319-2020-06662
    Event Type
    Injury
    Date Received
    October 12, 2020
    Date of Event
    October 6, 2020
    Report Date
    December 20, 2021
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-0067-2019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: THE CONTROLLER WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. A VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED HAIRLINE CRACKS AROUND BOTH POWER PORTS. AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THE OBSERVED HAIRLINE CRACKS ARE NOT RELATED TO THE REPORTED EVENT. BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00381374, THE ROOT CAUSE OF THE HAIRLINE CRACKS WAS DETERMINED TO BE DUE TO CHEMICAL ADDITIVES APPLIED TO THE POWER PORT GASKETS DURING THE MANUFACTURING PROCESS. THE CHEMICAL ADDITIVES CONTRIBUTED TO ENVIRONMENTAL STRESS CRACKING. EVEN THOUGH THIS CAPA IS CLOSED, THE CONTROLLER FALLS WITHIN THE BOUNDS OF THIS CAPA. FUNCTIONAL TESTING REVEALED THAT THE NO POWER ALARM ONLY SOUNDED BRIEFLY WHEN BOTH POWER SOURCES WERE DISCONNECTED, AND THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO AN ISSUE WITH THE INTERNAL BATTERY. INTERNAL INSPECTION REVEALED THAT THE INTERNAL NICKEL-METAL HYDRIDE (NIMH) BATTERY, WHICH POWERS THE NO POWER ALARM, WAS SWOLLEN. AFTER THE INTERNAL BATTERY WAS REPLACED, THE CONTROL LER PERFORMED AS INTENDED. LOG FILE ANALYSIS REVEALED ONE CONTROLLER FAULT ALARM LOGGED ON (B)(6) 2020 AT 15:49:28, INDICATING AN ISSUE WITH THE INTERNAL BATTERY. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. IN ADDITION, LOG FILES REVEALED THAT THE CONTROLLER WAS IN USE FOR MORE THAN TWO YEARS. THE MOST LIKELY ROOT CAUSE OF THE REPORTED CONTROLLER FAULT ALARM CAN BE ATTRIBUTED TO A REDUCED CHARGE CAPACITY OF THE INTERNAL NIMH BATTERY. CAPA PR00492825 WAS OPENED TO INVESTIGATE INTERNAL BATTERY ISSUES WITH CONTROLLER 2.0. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR A CORRECTION. CORRECTED FIELDS: H1 TYPE OF REPORT: UPDATED TO SERIOUS INJURY B1 ADV EVENT/PRODUCT PROBLEM UPDATED OUTCOME ATTRIBUTED TO ADVERSE EVENT SELECTED IN B2 THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION PER (B)(4) DUE TO AN FDA AUDIT OBSERVATION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE PATIENT WAS SITTING AT HOME AND HEARD A MEDIUM PRIORITY ALARM - STATING CONTROLLER FAULT ALARM, WHICH WAS TRIGGERED DUE TO A DEPLETING INTERNAL BATTERY OF THE CONTROLLER. THE PATIENT FELT FINE, WITH NO FURTHER COMPLICATIONS AND STATED THAT THERE WAS NO PREVIOUS ALARMS. THE EMERGENCY SERVICE ARRIVED AND PERFORMED A CONTROLLER EXCHANGE WITHOUT ANY COMPLICATIONS. THE PATIENT SPENT ONE DAY AT THE HOSPITAL FOR EXAMINATION AND IS DOING FINE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT WAS SITTING AT HOME AND HEARD A MEDIUM PRIORITY ALARM - STATING CONTROLLER FAULT ALARM, WHICH WAS TRIGGERED DUE TO A DEPLETING INTERNAL BATTERY OF THE CONTROLLER. THE PATIENT FELT FINE, WITH NO FURTHER COMPLICATIONS AND STATED THAT THERE WAS NO PREVIOUS ALARMS. THE EMERGENCY SERVICE ARRIVED AND PERFORMED A CONTROLLER EXCHANGE WITHOUT ANY COMPLICATIONS. THE PATIENT SPENT ONE DAY AT THE HOSPITAL FOR EXAMINATION AND IS DOING FINE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129865 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Hospitalization 1104 - VAD