HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER
Report
- Report Number
- 3007042319-2017-03487
- Event Type
- Malfunction
- Date Received
- October 2, 2017
- Date of Event
- August 16, 2017
- Report Date
- November 30, 2018
- Manufacturer
- HEARTWARE, INC
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-1903-2018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
THE CONTROLLER (CON304390), SIX BATTERIES (BAT204096, BAT204309, BAT204120, BAT214339, BAT217088, BAT218470), AND TWO CONTROLLER AC ADAPTERS (CAC010304, CAC009898) WERE RETURNED FOR EVALUATION. 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 AND CONTROLLER AC ADAPTERS REVEALED THAT THE BATTERIES AND CONTROLLER AC ADAPTERS ALL PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF THE CONTROLLER REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED A HAIRLINE CRACK SURROUNDING POWER PORT 2. AN INTERNAL VISUAL INSPECTION DID NOT REVEAL FLUID INGRESS. THE HAIRLINE CRACK IS NOT RELATED TO THE REPORTED EVENT. BASED ON AN INVESTIGATION CONDUCTED, 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 ENVIRONMENTAL STRESS CRACKING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, CON304390, CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF DATA FILES REVEALED POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS INVOLVING BAT204309, BAT204120, BAT214339, BAT217088, AND BAT218470. MOMENTARY DISCONNECTIONS WILL RESULT IN AN AUDIBLE TONE. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED BEEPING AND POWER SWITCHING EVENTS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS MOMENTARY DISCONNECTIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
DEVICE ANALYSIS, (B)(4): THE CONTROLLER PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. ADDITIONAL PRODUCTS: BATTERY - (B)(4). D10: YES, RETURN DATE: H3: YES H4: MFG DATE: H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 11 THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. BATTERY - (B)(4). D10: YES, RETURN DATE: 2017-10-23 H3: YES H4: MFG DATE: 2015-01-13 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 11 THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. BATTERY - (B)(4). D10: YES, RETURN DATE: 2017-10-23 H3: YES H4: MFG DATE: 2016-02-03 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 11 THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. BATTERY - (B)(4). D10: YES, RETURN DATE: 2017-10-24 H3: YES H4: MFG DATE: 2016-04-04 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 11 THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. CAC ADAPTER - (B)(4). D10: YES, RETURN DATE: 2017-10-24 H3: YES H6 FDA METHOD CODE(S): 10,23,38 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 71 CAC ADAPTER PASSED VISUAL AND FUNCTIONAL TESTING. CAC ADAPTER - (B)(4). D10: YES, RETURN DATE: 2017-10-24 H3: YES H6 FDA METHOD CODE(S): 10,23,38 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 71 CAC ADAPTER PASSED VISUAL AND FUNCTIONAL TESTING. THIS REPORT WAS IDENTIFIED FOLLOWING THE CONVERSION OF COMPLAINT FILES FROM THE LEGACY COMPLAINT HANDLING SYSTEM FOLLOWING INTEGRATION AND IS BEING SUBMITTED TO REPORT ANALYSIS RESULTS. 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.
ADDITIONAL DEVICE(S) INVOLVED IN EVENT: D4: (B)(4) ¿ BATTERY D10: YES, RETURN DATE: 2017-10-23 H4: 2015-01-07 H6. METHOD CODE(S): 10, 23, 38, 3372 H6. CONCLUSION CODE(S): 71 D4: (B)(4) - BATTERY H6. METHOD CODE(S): 10, 23, 38, 3372 H6. CONCLUSION CODE(S): 25 D4: (B)(4) ¿ BATTERY H6. METHOD CODE(S): 10, 23, 38, 3372 H6. CONCLUSION CODE(S): 25 D4: (B)(4) - BATTERY H6. METHOD CODE(S): 10, 23, 38, 3372 H6. CONCLUSION CODE(S): 25 D4: (B)(4) - BATTERY H6. METHOD CODE(S): 10, 23, 38, 3372 H6. CONCLUSION CODE(S): 25 D4: (B)(4) - BATTERY H6. CONCLUSION CODE(S):25 D4: (B)(4) - CONTROLLER AC ADAPTER H6. METHOD CODE(S): 3372 H6. CONCLUSION CODE(S): 71 D4: (B)(4) - CONTROLLER AC ADAPTER H6. METHOD CODE(S): 3372 H6. CONCLUSION CODE(S): 71 THE CONTROLLER (B)(4), SIX BATTERIES (B)(4), AND TWO CONTROLLER AC ADAPTERS (B)(4) WERE RETURNED FOR EVALUATION. 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 DEVICES REVEALED THAT THE CONTROLLER, BATTERIES, AND CONTROLLER AC ADAPTERS ALL PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, (B)(4), CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF DATA FILES REVEALED POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4). MOMENTARY DISCONNECTIONS WILL RESULT IN AN AUDIBLE TONE. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED BEEPING AND POWER SWITCHING EVENTS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS MOMENTARY DISCONNECTIONS. 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.
OTHER DEVICES INVOLVED IN THIS EVENT: BATTERY/ (B)(4), DEVICE AVAILABLE FOR EVALUATION: YES, 2017-10-24, DEVICE EVALUATED BY MFR: YES, DEVICE MANUFACTURE DATE: 2015-01-07. THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION, FUNCTIONAL CHECKS AND MACCOR TESTING. BATTERY/ (B)(4), DEVICE AVAILABLE FOR EVALUATION: YES, 2017-10-23, DEVICE EVALUATED BY MFR: YES, DEVICE MANUFACTURE DATE: 2016-05-21, THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION, FUNCTIONAL CHECKS AND MACCOR TESTING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
**OTHER DEVICES INVOLVED IN THIS EVENT: CONTROLLER AC ADAPTER - CAC009898 / CATALOG NUMBER 1430DE / EXPIRATION DATE: UNK. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MANUFACTURER: NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE: NO. (B)(4). CONTROLLER AC ADAPTER - CAC010290 / CATALOG NUMBER 1430DE / EXPIRATION DATE: UNK. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MANUFACTURER: NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE: NO. (B)(4). BATTERY/ (B)(4) / CATALOG NUMBER 1650DE / EXPIRATION DATE: 2017/05/31. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MANUFACTURER: NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE: NO. (B)(4). BATTERY/ (B)(4)/ CATALOG NUMBER 1650DE / EXPIRATION DATE: 2017/04/30. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MANUFACTURER: NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE:NO. H6:DEVICE CODE(S): BATTERY ISSUE C63030; FDA 2885. BATTERY/ (B)(4)/ CATALOG NUMBER 1650DE / EXPIRATION DATE: 2017/02/28. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MANUFACTURER: NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE: NO. (B)(4). BATTERY/ (B)(4)/ CATALOG NUMBER 1650DE / EXPIRATION DATE: 2016/01/31. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MANUFACTURER: NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE: NO. (B)(4). BATTERY/ (B)(4) / CATALOG NUMBER 1650DE / EXPIRATION DATE: 2016/01/31. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MANUFACTURER: NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE: NO. (B)(4). BATTERY/ (B)(4) / CATALOG NUMBER 1650DE / EXPIRATION DATE: 2016/01/31. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MANUFACTURER: NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE: NO. (B)(4). THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED BY THE PATIENT THAT THE CONTROLLER WAS BEEPING AND EXHIBITED SWITCHING BETWEEN POWER CONNECTIONS DESPITE THE BATTERY CAPACITY. THE CONTROLLER, CONTROLLER AC ADAPTERS, AND ASSOCIATED BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 686456 | HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER | CIRCULATORY ASSIST SYSTEM, | DSQ | HEARTWARE, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |