HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2024-04236
- Event Type
- Malfunction
- Date Received
- July 31, 2024
- Date of Event
- July 28, 2024
- Report Date
- November 26, 2024
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL#: 1650 / CATALOG#: 1650 / EXPIRATION DATE: 31-MARCH-2024 / SERIAL#: BAT (B)(6) D9: NO H3: NO H4: MFG DATE: 02-MARCH-2023 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL#: 1650 / CATALOG#: 1650 / EXPIRATION DATE: 31-MARCH-2024 / SERIAL#: BAT (B)(6) D9: NO H3: NO H4: MFG DATE: 02-MARCH-2023 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL#: 1650 / CATALOG#: 1650 / EXPIRATION DATE: 31-MARCH-2024 / SERIAL#: BAT(B)(6) D9: NO H3: NO H4: MFG DATE: 08-MARCH-2023 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL#: 1650 / CATALOG#: 1650 / EXPIRATION DATE: 31-MARCH-2024 / SERIAL#: BAT (B)(6) D9: NO H3: NO H4: MFG DATE: 09-MARCH-2023 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL#: 1650 / CATALOG#: 1650 / EXPIRATION DATE: 31-MARCH-2024 / SERIAL#: BAT (B)(6) D9: NO H3: NO H4: MFG DATE: 09-MARCH-2023 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL#: 1650 / CATALOG#: 1650 / EXPIRATION DATE: 31-MARCH-2024 / SERIAL#: BAT( B)(6) D9: NO H3: NO H4: MFG DATE: 09-MARCH-2023 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER D4: MODEL#: 1430 / CATALOG#: 1430 / EXPIRATION DATE: / SERIAL#: D9: NO H3: NO H4: MFG DATE: H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER DC ADAPTER D4: MODEL#: 1440 / CATALOG#: 1440 / EXPIRATION DATE: / SERIAL#: D9: NO H3: NO H4: MFG DATE: H5: NO MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION WAS RECEIVED. H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. ADDITIONAL PRODUCTS: D1: CONTROLLER AC ADAPTER D4: SERIAL#: (B)(6) D1: CONTROLLER DC ADAPTER D4: EXPIRATION DATE: 30-APR-2024 /SERIAL#: (B)(6) H4: MFG DATE: 18-OCT-2021. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION SUMMARY. ADDITIONAL PRODUCTS: SERIAL#: (B)(6) H3: YES SERIAL#: (B)(6) H3: YES SERIAL#: (B)(6) H3: YES SERIAL#: (B)(6) H3: YES SERIAL#: (B)(6) H3: YES SERIAL#: (B)(6) H3: YES SERIAL#:(B)(6) H3: YES SERIAL#:(B)(6) H3: YES H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. PRODUCT EVENT SUMMARY: ONE CONTROLLER ((B)(6)), FOUR (4) BATTERIES ((B)(6)), ONE (1) CONTROLLER AC ADAPTER, ONE (1) CONTROLLER DC ADAPTER, WERE RETURNED FOR EVALUATION. TWO (2) BATTERIES ((B)(6)) WERE NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED AS THE REPORTED EVENT IS NOT RELATED TO A MANUFACTURING OR SERVICING ISSUE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED DEVICES REVEALED THAT ALL DEVICES PASSED FUNCTIONAL TESTING. VISUAL INSPECTION OF (B)(6) REVEALED CONTAMINATION WITHIN THE SERIAL PORT, AND BOTH POWER PORTS. SUPPLEMENTAL TESTING WAS PERFORMED, AND THE TEST RESULTS REVEALED CONTAMINATION ON THE PINS AND THAT THE GOLD-PLATING OF THE PINS WERE WORN, EXPOSING THE BASE METAL. THE EXPOSURE OF THE BASE METAL IS SUSCEPTIBLE TO THE EFFECTS OF CORROSION; NO DAMAGE WAS OBSERVED WITH THE CONTROLLER RECEPTACLES' SPRINGS AND TROUGHS. AN INTERNAL VISUAL INSPECTION REVEALED A CRACK ON STANDOFF POST FIVE (5) WITHIN THE CONTROLLER HOUSING; THIS IS AN ADDITIONAL FINDING, NOT RELATED TO THE REPORTED EVENT. BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00381374, THE ROOT CAUSE OF THE HAIRLINE CRACK WAS DE TERMINED TO BE DUE TO CHEMICAL ADDITIVES APPLIED TO THE POWER PORT GASKETS DURING THE MANUFACTURING PROCESS. THE CHEMICAL ADDITIVES CONTRIBUTED TO ENVIRONMENTAL STRESS CRACKING. EVEN THOUGH THIS CAPA IS CLOSED, (B)(6) FALLS WITHIN THE BOUNDS OF THIS CAPA. VISUAL INSPECTION OF THE REMAINING RETURNED DEVICES DID NOT REVEAL ANY ABNORMALITIES. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER IN USE DURING THE REPORTED EVENT ((B)(6)) 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 FILE REVEALED SEVERAL INSTANCES OF PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(6); AS WELL AS SEVERAL MOMENTARY DISCONNECTIONS THAT DID NOT LEAD TO PREMATURE POWER SWITCHING INVOLVING (B)(6), AND POWER ADAPTERS. MOMENTARY DISCONNECTIONS WILL RESULT IN AN AUDIBLE TONE OR 'BEEP'. THE ASSOCIATED BATTERIES AND POWER ADAPTERS HAD BEEN LUBRICATED PRIOR TO RELEASE. IN ADDITION, LOG FILES REVEALED THAT THE CONTROLLER HAD BEEN INITIALLY PROGRAMMED MORE THAN TWO (2) YEARS AGO. LOG FILE ANALYSIS REVEALED ONE (1) VAD DISCONNECT ALARM LOGGED ON (B)(6) 2024, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER MOST LIKELY DUE TO A CONTROLLER EXCHANGE. AS A RESULT, THE REPORTED BEEPING AND DATA PORT CONTAMINATION EVENTS WERE CONFIRMED. THE REPORTED POOR MECHANICAL CONNECTION, BENT PINS, AND CONTROLLER POWER ADAPTER CONTAMINATION EVENTS WERE NOT CONFIRMED. THE REPORTED POOR MECHANICAL CONNECTION EVENT COULD BE RELATED TO THE POWER SWITCHING EVENT. BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00574181 AND THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED BEEPING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS DUE TO FRETTING CORROSION OF THE POWER-SOURCE PINS, AND/OR CONTAMINATION ON THE CONTROLLER RECEPTACLE SOCKETS/POWER SOURCE PINS. EVEN THOUGH THIS CAPA IS NOW CLOSED, (B)(6), ASSOCIATED BATTERIES AND ADAPTERS FALL IN SCOPE OF THIS CAPA. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED CONTAMINATION EVENTS CAN BE ATTRIBUTED TO THE HANDLING OF THE DEVICE. A POSSIBLE CAUSE OF THE REPORTED BENT PINS EVENT COULD NOT BE DETERMINED BECAUSE THE RETURNED DEVICES TESTED WITHIN SPECIFICATION AND THE ISSUE COULD NOT BE DUPLICATED. 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 SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED AS ADDITIONAL INFORMATION HAS BEING RECEIVED FOR THIS EVENT AND SECTIONS HAVE BEEN UPDATED. ADDITIONAL PRODUCT: D4: MODEL #: 1430/ CATALOG #:1430/ EXPIRATION DATE:31-MAR-2025 /SERIAL OR LOT#:(B)(6). H4: MFG DATE: 01-MAR-2022 H5: NO. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
IT WAS REPORTED THAT THE CONTROLLER AND BATTERIES EXHIBITED UNSTABLE POOR MECHANICAL CONNECTION. THE CONTROLLER DUE TO SUSPECTED CONTAMINATION OF THE DATA PORT AND THE BATTERIES DUE TO BENT/BROKEN PINS. THE CONTROLLER ALSO EXHIBITED RANDOM BEEPING WHEN A POWER SOURCE WAS DISCONNECTED OR RECONNECTED. THE CONTROLLER AC (CAC) AND DC (CDC) ADAPTER PORTS WERE ALSO SUSPECTED OF BEING CONTAMINATED. IT WAS NOTED THAT THE PATIENT IS VERY ACTIVE AND WORKS IN A TOOL SHED WHERE PARTICLES MAY HAVE CAUSED THE CONTAMINATION. THE CONTROLLER, CAC AND CDC ADAPTERS WERE REMOVED FROM SERVICE AND THE BATTERIES REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 912852 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male | 1104 VAD. |