SYNCARDIA COMPANION 2 DRIVER
Report
- Report Number
- 3003761017-2015-00301
- Event Type
- Malfunction
- Date Received
- September 28, 2015
- Date of Event
- September 11, 2015
- Report Date
- September 15, 2015
- Manufacturer
- SYNCARDIA SYSTEMS, INC.
- Product Code
- LOZ
- PMA / PMN Number
- P030011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
(B)(4).
(B)(4).
THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED NUMEROUS ALARM MESSAGES WHILE SUPPORTING A PATIENT AT THE (B)(6). THE CUSTOMER ALSO REPORTED THAT THE ALARM MESSAGES COULD NOT BE CONTROLLED DESPITE SEVERAL ATTEMPTS TO OPTIMIZE THE DRIVER'S SETTINGS. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP COMPANION 2 DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE PATIENT FILE WAS COPIED AND REVIEWED. THIS REVEALED RIGHT OVERPRESSURE ALARMS, A SINGLE COMPRESSOR MALFUNCTION ALARM AND A SYSTEM MALFUNCTION ALARM CONFIRMING THE CUSTOMER REPORTED ISSUE OF MULTIPLE ALARMS. MULTIPLE EXTERNAL AIR CONNECTED NOTIFICATIONS WERE ALSO RECORDED. EFFORTS TO DUPLICATE THE SINGLE COMPRESSOR MALFUNCTION ALARM AND SYSTEM MALFUNCTION ALARM WERE SUCCESSFUL DURING FAILURE INVESTIGATION TESTING WITH THE ROOT CAUSE BEING A MALFUNCTION OF THE PRESSURE SENSOR PRINTED CIRCUIT ASSEMBLY (PCA). THE PRESSURE SENSOR PCA WAS REPLACED DURING THE SERVICING OF THE DRIVER. EFFORTS TO DUPLICATE THE RIGHT OVERPRESSURE ALARMS WERE NOT SUCCESSFUL DURING FAILURE INVESTIGATION TESTING. EFFORTS TO DUPLICATE THE EXTERNAL AIR CONNECTED NOTIFICATIONS WERE SUCCESSFUL DURING FAILURE INVESTIGATION TESTING WITH THE ROOT CAUSE BEING A MALFUNCTION OF THE MANUAL PRESSURE REGULATOR. THE MANUAL PRESSURE REGULATOR WAS REPLACED DURING SERVICING OF THE DRIVER. THE ISSUE OF COMPRESSOR CYCLING BECAUSE OF A MALFUNCTION OF THE MANUAL PRESSURE REGULATOR IS BEING INVESTIGATED IN A CAPA (CORRECTIVE OR PREVENTIVE ACTION). THE CAPA WILL DOCUMENT THE INVESTIGATION INCLUDING, BUT NOT LIMITED TO, POTENTIAL ROOT CAUSE AND CORRECTIVE ACTIONS ASSOCIATED WITH COMPRESSOR CYCLING BECAUSE OF A MALFUNCTION OF THE MANUAL PRESSURE REGULATOR. THE COMPANION 2 DRIVER WAS SERVICED AND PASSED ALL FUNCTIONAL AND PERFORMANCE TESTING BEFORE BEING PLACED INTO FINISHED GOODS. ALTHOUGH THE MULTIPLE ALARMS OCCURRED, THE RISK TO THE PATIENT WOULD HAVE BEEN LOW BECAUSE THE INITIAL EVALUATION OF THE DRIVER DEMONSTRATED THAT THE DRIVER CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. ADDITIONALLY, CENTERS ARE EQUIPPED WITH BACKUP DRIVERS. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE.
THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED NUMEROUS ALARM MESSAGES WHILE SUPPORTING A PATIENT AT THE (B)(6). THE CUSTOMER ALSO REPORTED THAT THE ALARM MESSAGES COULD NOT BE CONTROLLED DESPITE SEVERAL ATTEMPTS TO OPTIMIZE THE DRIVER'S SETTINGS. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP COMPANION 2 DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THE COMPANION 2 DRIVER EXHIBITED ALARM MESSAGES, IT DID NOT PREVENT THE DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION 2 DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638569 | SYNCARDIA COMPANION 2 DRIVER | EXTERNAL PNEUMATIC DRIVER | LOZ | SYNCARDIA SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |