HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY
Report
- Report Number
- 3007042319-2020-00207
- Event Type
- Malfunction
- Date Received
- January 22, 2020
- Date of Event
- January 20, 2020
- Report Date
- March 11, 2020
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: FOUR (4) BATTERIES 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 ALL THE BATTERIES PASSED FUNCTIONAL TESTING. ADDITIONALLY, IT WAS OBSERVED THAT BATTERIES HAD EXCEEDED THE USEFUL OPERATING LIFE OF 500 CHARGE AND DISCHARGE CYCLES. THE HIGH BATTERY CYCLE COUNTS ARE AN ADDITIONAL OBSERVATION UNRELATED TO THE REPORTED EVENT AND CAN BE ATTRIBUTED TO THE BATTERIES REACHING THE END OF THEIR USEFUL LIFE. VISUAL INSPECTION REVEALED WORN MARKS ON ALL THE BATTERIES OUTPUT CONNECTORS. AS A RESULT, THE REPORTED "WORN" EVENT WAS CONFIRMED. VISUAL INSPECTION ALSO REVEALED THAT THE RELEASE INDICATOR MARKER ON ONE BATTERY'S OUTPUT CONNECTOR WAS ILLEGIBLE, LIKELY DUE TO WEAR AND/OR TO THE HANDLING OF THE DEVICE. THESE FINDINGS THAT WAS OBSERVED DID NOT AFFECT THE FUNCTIONALITY OF THE DEVICE; THE BATTERIES WERE ABLE TO ADEQUATELY CONNECT TO A TEST CONTROLLER. AS A R RESULT, THE REPORTED POOR MECHANICAL CONNECTION EVENT COULD NOT BE CONFIRMED; HOWEVER, IT IS LIKELY THE WORN OUTPUT CONNECTORS AND/OR AN ILLEGIBLE RELEASE MARKER CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO WEAR, LIKELY DUE TO NORMAL DISCONNECTION AND RE-CONNECTION BETWEEN THE BATTERY OUTPUT CABLE AND METAL POWER PORT CONNECTORS ON THE CONTROLLER. AN INTERNAL INVESTIGATION WAS OPENED TO INVESTIGATE DAMAGED BATTERY CONNECTORS. ADDITIONAL PRODUCTS: D4: SERIAL OR LOT#: (B)(6). H3: YES H6: FDA METHOD CODE(S): 10 H6: FDA RESULTS CODE(S): 180, 213 H6: FDA CONCLUSION CODE(S): 19, 133 D4: SERIAL OR LOT#: (B)(6). D10: YES, RETURN DATE: 25-FEB-2020 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 10 H6: FDA RESULTS CODE(S): 180, 213 H6: FDA CONCLUSION CODE(S): 19, 133 D4: SERIAL OR LOT#: (B)(6). H3: YES H6: FDA METHOD CODE(S): 10 H6: FDA RESULTS CODE(S): 135, 180, 213 H6: FDA CONCLUSION CODE(S): 19, 133 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 PRODUCTS: D4: SERIAL OR LOT#: (B)(6). D10: YES, RETURN DATE: 03-FEB-2020 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN DEV RTN TO MFR? YES. H6: FDA RESULTS CODE(S): 3233 H6: FDA CONCLUSION CODE(S): 11 D4: SERIAL OR LOT#: (B)(6). D10: YES, RETURN DATE: 03-FEB-2020 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN DEV RTN TO MFR? YES H6: FDA RESULTS CODE(S): 3233 H6: FDA CONCLUSION CODE(S): 11. 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.
ALL OF THE BATTERIES WERE REMOVED FROM SERVICE.
THREE BATTERIES WERE REMOVED FROM SERVICE.
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. ADDITIONAL PRODUCTS: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 30-APR-2016 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4). MFG DATE: 30-APR-2015. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 30-APR-2016 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4), MFG DATE: 30-APR-2015. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 30-APR-2016 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4), MFG DATE: 30-APR-2015. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE BATTERIES HAD POOR MECHANICAL CONNECTIONS THAT WERE "WORN" AND THE BATTERIES HAD DIFFICULTIES BEING ATTACHED TO A CONTROLLER. THE BATTERIES WERE EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 81834 | HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | 1650DE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1104 VAD. |