HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2018-02481
- Event Type
- Malfunction
- Date Received
- June 14, 2018
- Date of Event
- May 23, 2018
- Report Date
- October 4, 2018
- 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
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
PRODUCT EVENT SUMMARY: PLI 10: THE RETURNED CONTROLLER (B)(4) PASSED FUNCTIONAL TESTING BUT VISUAL INSPECTION REVEALED CRACKS AROUND POWER PORT 2. ADDITIONAL PRODUCTS: BATTERY, (B)(4). D4 EXPIRATION DATE: 2017-06-30 UDI#: (B)(4). D10: YES, RETURN DATE: 2018-06-05 H3: YES H4: MFG DATE: 2016-06-30 H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY (B)(4) PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. BATTERY, (B)(4). D4 EXPIRATION DATE: 2017-02-28 UDI#: (B)(4). D10: YES, RETURN DATE: 2018-06-05 H3: YES H4: MFG DATE: 2016-02-28 H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY (B)(4) PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. BATTERY, (B)(4). D4 EXPIRATION DATE: 2017-03-31 UDI#: (B)(4). D10: YES, RETURN DATE: 2018-06-05 H3: YES H4: MFG DATE: 2016-03-31 H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY (B)(4) PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. BATTERY, (B)(4). D4 EXPIRATION DATE: 2017-08-31 UDI#: (B)(4). D10: YES, RETURN DATE: 2018-06-05 H3: YES H4: MFG DATE: 2016-08-31 H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY (B)(4). PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. BATTERY, (B)(4). D4 EXPIRATION DATE: 2017-06-30 UDI#: (B)(4). D10: YES, RETURN DATE: 2018-06-05 H3: YES H4: MFG DATE: 2016-06-30 H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY (B)(4) PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. BATTERY, (B)(4). D4 EXPIRATION DATE: 2017-06-30 UDI#: (B)(4). D10: YES, RETURN DATE: 2018-06-05 H3: YES H4: MFG DATE: 2016-06-30 H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY (B)(4) PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. 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.
PRODUCT EVENT SUMMARY: THE CONTROLLER (CON307124) AND SIX BATTERIES (BAT322640, BAT315666, BAT320587, BAT322744, BAT322077, BAT322010) WERE RETURNED FOR EV ALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE BATTERIES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF CONTROLLER REVEALED THAT THE CONTROLLER PASSED FUNCTIONAL TESTING. VISUAL INSPECTION OF THE CONTROLLER UNDER 10X MAGNIFICATION REVEALED A HAIRLINE CRACK AROUND POWER PORT 2. AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THE OBSERVED HAIRLINE CRACK IS NOT RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE HAIRLINE CRACK WAS DETERMINED TO BE DUE TO CHEMICAL ADDITIVES APPLIED TO THE POWER PORT GASKETS DURING THE MANUFACTURING PROCESS. THE CHEMICAL ADDITIVES CONTRIBUTED TO ENVIRONMENT STRESS CRACKING. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO EVALUATE THE HAIRLINE CRACKS AND IMPLEMENT CORRECTIVE ACTIONS AS REQUIRED. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, CON307124, 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 ONE PREMATURE POWER SWITCHING EVENT DUE TO A MOMENTARY DISCONNECTION INVOLVING BAT322077. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A MOMENTARY DISCONNECTION BETWEEN THE CONTROLLER AND BATTERY. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO EVALUATE THE MOMENTARY DISCONNECTIONS AND IMPLEMENT CORRECTIVE ACTIONS AS REQUIRED. CORRECTION FOR PREVIOUS REPORT: SECTION D11: CONCOMITANT PRODUCT AND THERAPY DATE 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.
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: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30. UDI #: (B)(4). RETURN DATE: 2018-06-05. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-06-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-02-28. UDI #: (B)(4). RETURN DATE: 2018-06-05. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-02-28. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-03-31. UDI #: (B)(4). RETURN DATE: 2018-06-05. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-03-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-08-31. UDI #: (B)(4). RETURN DATE: 2018-06-05. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-08-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30. UDI #: (B)(4). RETURN DATE: 2018-06-05. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-06-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30. UDI #: (B)(4). RETURN DATE: 2018-06-05. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-06-30. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED POWER SWITCHING ON THEIR DEVICES WHILE AT HOME. THE SITE NOTED THAT THE CHARGE ON THE BATTERIES WAS GREATER THAN TWENTY-FIVE PERCENT AT THE TIME OF THE EVENT. 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 |
|---|---|---|---|---|---|---|---|
| 444751 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1420 | 00888707000420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | (B)(4).| (B)(4). |