HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2018-00496
- Event Type
- Malfunction
- Date Received
- February 5, 2018
- Date of Event
- January 2, 2018
- Report Date
- October 10, 2018
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-0067-2019, Z-1903-2018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
PRODUCT EVENT SUMMARY: ONE CONTROLLER ((B)(4)), EIGHT BATTERIES ((B)(4)), THREE 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 CONTROLLER AC ADAPTERS, AND SEVEN BATTERIES ((B)(4)) REVEALED THAT THE DEVICES PASSED FUNCTIONAL TESTING AND VISUAL EXAMINATION. VISUAL INSPECTION OF (B)(4) REVEALED DAMAGE TO THE STRAIN RELIEF OF THE BATTERY CABLE; THE DAMAGE THAT WAS OBSERVED DID NOT AFFECT THE FUNCTIONALITY OF THE DEVICE. THIS IS AN ADDITIONAL OBSERVATION NOT RELATED TO THE REPORTED EVENT, LIKELY DUE TO WEAR AND/OR HANDLING OF THE DEVICE. FAILURE ANALYSIS REVEALED THAT THE CONTROLLER PASSED FUNCTIONAL TESTING; VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED HAIRLINE CRACKS AROUND POWER PORT TWO (2). 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, 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. 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 THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4). AS A RESULT, THE REPORTED POWER SWITCHING EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION WAS OPENED TO EVALUATE MOMENTARY DISCONNECTIONS. (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.
OTHER DEVICES ASSOCIATED WITH THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ AC ADAPTER, MODEL 1430DE / EXPIRATION DATE UNKNOWN / SERIAL NUMBER (B)(4) / UDI UNKNOWN. IS THIS A SINGLE-USE DEVICE?: NO. DEVICE AVAILABLE FOR EVALUATION: YES / RETURNED 25JAN2018. MFG DATE UNKNOWN. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ AC ADAPTER, MODEL 1430DE / EXPIRATION DATE UNKNOWN / SERIAL NUMBER (B)(4) / UDI UNKNOWN, IS THIS A SINGLE-USE DEVICE? NO. DEVICE AVAILABLE FOR EVALUATION: YES / RETURNED 25JAN2018. MFG DATE UNKNOWN. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ AC ADAPTER, MODEL 1430DE / EXPIRATION DATE UNKNOWN / SERIAL NUMBER (B)(4) / UDI UNKNOWN, IS THIS A SINGLE-USE DEVICE: NO. DEVICE AVAILABLE FOR EVALUATION: YES / RETURNED 25JAN2018. MFG DATE UNKNOWN. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL 1650DE / EXPIRATION DATE UNKNOWN / SERIAL NUMBER (B)(4) / UDI UNKNOWN, IS THIS A SINGLE-USE DEVICE?: NO. DEVICE AVAILABLE FOR EVALUATION: YES / RETURNED 25JAN2018. MFG DATE UNKNOWN. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL 1650DE / EXPIRATION DATE 30JUN2017 / SERIAL NUMBER (B)(4) / UDI UNKNOWN, IS THIS A SINGLE-USE DEVICE: NO. DEVICE AVAILABLE FOR EVALUATION: YES / RETURNED 25JAN2018. MFG DATE 30JUN2016. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL 1650DE / EXPIRATION DATE 28FEB2017 / SERIAL NUMBER (B)(4) / UDI UNKNOWN, IS THIS A SINGLE-USE DEVICE?: NO. DEVICE AVAILABLE FOR EVALUATION: YES / RETURNED 25JAN2018. MFG DATE 28FEB2016. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL 1650DE / EXPIRATION DATE 30NOV2016 / SERIAL NUMBER (B)(4) / UDI UNKNOWN, IS THIS A SINGLE-USE DEVICE?:: NO. DEVICE AVAILABLE FOR EVALUATION: YES / RETURNED 25JAN2018. MFG DATE 30NOV2015. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL 1650DE / EXPIRATION DATE 31JUL2018 / SERIAL NUMBER (B)(4) / UDI UNKNOWN, IS THIS A SINGLE-USE DEVICE: NO, DEVICE AVAILABLE FOR EVALUATION: YES / RETURNED 25JAN2018. MFG DATE 31JUL2017. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL 1650DE / EXPIRATION DATE 30NOV2016 / SERIAL NUMBER (B)(4) / UDI UNKNOWN. IS THIS A SINGLE-USE DEVICE?: NO. DEVICE AVAILABLE FOR EVALUATION: YES / RETURNED 25JAN2018. MFG DATE 30NOV2015 LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL 1650DE / EXPIRATION DATE 30JUN2017 / SERIAL NUMBER (B)(4)/ UDI UNKNOWN, IS THIS A SINGLE-USE DEVICE?: NO. DEVICE AVAILABLE FOR EVALUATION: YES / RETURNED 25JAN2018. MFG DATE 30JUN2016 LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL 1650DE / EXPIRATION DATE 30JUN2017 / SERIAL NUMBER (B)(4) / UDI UNKNOWN, IS THIS A SINGLE-USE DEVICE?: NO. DEVICE AVAILABLE FOR EVALUATION: YES / RETURNED 25JAN2018. MFG DATE 30JUN2016 LABELED FOR SINGLE USE: NO. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION INCLUDES THE RETURN OF THE PATIENT¿S CONTROLLER, THREE CONTROLLER AC ADAPTERS AND EIGHT BATTERIES; INCLUDING (B)(4).
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 ASSOCIATED WITH THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ AC ADAPTER, MODEL 1430DE / EXPIRATION DATE: UNKNOWN / SERIAL NUMBER (B)(4) / UDI UNKNOWN, MFG DATE: UNKNOWN, (B)(4), DEVICE NOT RETURNED. HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ AC ADAPTER, MODEL 1430DE / EXPIRATION DATE UNKNOWN / SERIAL NUMBER (B)(4) / UDI UNKNOWN, MFG DATE UNKNOWN, (B)(4), DEVICE NOT RETURNED. HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ AC ADAPTER, MODEL 1430DE / EXPIRATION DATE UNKNOWN / SERIAL NUMBER (B)(4) / UDI UNKNOWN, MFG DATE UNKNOWN, (B)(4), DEVICE NOT RETURNED. HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL 1650DE / EXPIRATION DATE UNKNOWN / SERIAL NUMBER (B)(4) / UDI UNKNOWN, MFG DATE UNKNOWN, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL 1650DE / EXPIRATION DATE 30JUN2017 / SERIAL NUMBER (B)(4) / UDI UNKNOWN, MFG DATE 30JUN2016, (B)(4), DEVICE NOT RETURNED. HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL 1650DE / EXPIRATION DATE 28FEB2017 / SERIAL NUMBER (B)(4) / UDI UNKNOWN, MFG DATE 28FEB2016, (B)(4), DEVICE NOT RETURNED. HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL 1650DE / EXPIRATION DATE 30NOV2016 / SERIAL NUMBER (B)(4) / UDI UNKNOWN, MFG DATE 30NOV2015, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL 1650DE / EXPIRATION DATE 31JUL2018 / SERIAL NUMBER (B)(4) / UDI UNKNOWN, MFG DATE 31JUL2017, DEVICE NOT RETURNED. HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL 1650DE / EXPIRATION DATE 30NOV2016 / SERIAL NUMBER: (B)(4) / UDI UNKNOWN, MFG DATE 30NOV2015, (B)(4), DEVICE NOT RETURNED, HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL 1650DE / EXPIRATION DATE 30JUN2017 / SERIAL NUMBER (B)(4) / UDI UNKNOWN, MFG DATE 30JUN2016, (B)(4), DEVICE NOT RETURNED. 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.
A REPORT WAS RECEIVED THAT A PATIENT¿S CONTROLLER, AC ADAPTERS AND BATTERIES WERE ASSOCIATED WITH POWER SWITCHING. ALL DEVICES EXCEPT (B)(4), WHICH REMAINS IN USE, 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 |
|---|---|---|---|---|---|---|---|
| 86409 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1420-MCS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN PUMP |