HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2018-02336
- Event Type
- Malfunction
- Date Received
- June 11, 2018
- Date of Event
- May 4, 2018
- Report Date
- August 14, 2019
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707000420
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-1903-2018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
PRODUCT EVENT SUMMARY: ONE CONTROLLER AND SIX BATTERIES WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED A HAIRLINE CRACK ON THE CONTROLLER HOUSING. AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THE OBSERVED HAIRLINE CRACK IS NOT RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED HAIRLINE CRACKS CAN BE ATTRIBUTED TO HANDLING OF THE DEVICE. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A SOFTWARE WITH A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. DATA LOG FILES REVEALED MULTIPLE INSTANCES INVOLVING BAT587511, BAT584557 AND BAT587513 WHERE THE BATTERIES¿ RELATIVE STATE OF CHARGE (RSOC) WAS BETWEEN 101-201, WHICH ARE INDICATIVE OF COMMUNICATION ERRORS. ANALYSIS OF THE ALARM LOG FILES REVEALED ONE CRITICAL BATTERY ALARM DUE TO COMMUNICATION ERRORS INVOLVING BAT587511. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING BATTERIES BAT587513, BAT587512, BAT587511, BAT587510, BAT587508, BAT584557 AND POWER SWITCHING DUE TO COMMUNICATION ERRORS INVOLVING BATTERY BAT584557. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED CRITICAL BATTERY EVENT CAN BE ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY. POSSIBLE ROOT CAUSES OF THE REPORTED COMMUNICATION ERRORS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS ON THE COMMUNICATION PINS OF THE CONTROLLER, THE CONTROLLER NOT RECEIVING RESPONSES FROM THE BATTERY, AND/OR DUE TO THE PACKET ERROR CHECKING METHOD DETECTING BIT ERRORS. AN INTERNAL INVESTIGATION WAS COMPLETED TO INVESTIGATE MOMENTARY DISCONNECTIONS. THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. 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.
PRODUCT EVENT SUMMARY: ONE CONTROLLER AND SIX BATTERIES WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED A HAIRLINE CRACK ON THE CONTROLLER HOUSING. AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THE OBSERVED HAIRLINE CRACK IS NOT RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED HAIRLINE CRACKS CAN BE ATTRIBUTED TO HANDLING OF THE DEVICE. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15 MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING BATTERIES (B)(4) AND POWER SWITCHING DUE TO COMMUNICATION ERRORS INVOLVING BATTERY (B)(4). AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO EVALUATE MOMENTARY DISCONNECTIONS AND IMPLEMENT CORRECTIVE ACTIONS AS REQUIRED. (B)(4). MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
LOG FILE REVIEW INDICATED THAT ONE BATTERY EXHIBITED A CRITICAL BATTERY ALARM AND TWO BATTERIES EXHIBITED COMMUNICATION ERRORS.
THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. OTHER DEVICES INVOLVED IN THIS EVENT: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY: BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 10/31/2018, UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: YES, RETURN DATE: 05/23/2018, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MANUFACTURE DATE: MFG DATE: 10/28/2017, LABELED FOR SINGLE USE: NO. BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY: BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 08/31/2018, UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: YES, RETURN DATE: 05/23/2018, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MANUFACTURE DATE: MFG DATE: 08/31/2017, LABELED FOR SINGLE USE: NO. BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY: BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 10/31/2018, UDI #:(B)(4), DEVICE AVAILABLE FOR EVALUATION: YES, RETURN DATE: 05/23/2018, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MANUFACTURE DATE: MFG DATE: 10/28/2017, LABELED FOR SINGLE USE: NO. BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY: BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 10/31/2018, UDI #:(B)(4), DEVICE AVAILABLE FOR EVALUATION: YES, RETURN DATE: 05/23/2018, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MANUFACTURE DATE: MFG DATE: 10/28/2017, LABELED FOR SINGLE USE: NO. BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY: BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 10/31/2018, UDI #:(B)(4), DEVICE AVAILABLE FOR EVALUATION: YES, RETURN DATE: 05/23/2018, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MANUFACTURE DATE: MFG DATE: 10/28/2017, LABELED FOR SINGLE USE: NO. BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY: BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 10/31/2018, UDI #:(B)(4), DEVICE AVAILABLE FOR EVALUATION: YES, RETURN DATE: 05/23/2018, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MANUFACTURE DATE: MFG DATE: 10/28/2017, LABELED FOR SINGLE USE: NO. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POWER SWITCHING WHILE AT HOME. THE SITE NOTED THAT THE CHARGE ON THE BATTERIES DURING THE SWITCHING EVENTS WERE GREATER THAN TWENTY-FIVE PERCENT. ALL OF THE DEVICES HAVE BEEN EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 430357 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | 1420 | 00888707000420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | MCS UNKNOWN VAD| MCS UNKNOWN VAD |