ADVANCED PERFUSION SYSTEM 1
Report
- Report Number
- 1828100-2019-00532
- Event Type
- Malfunction
- Date Received
- October 7, 2019
- Date of Event
- September 13, 2019
- Report Date
- May 20, 2020
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.
THE REPORTED COMPLAINT WAS CONFIRMED. THE SERVICE REPAIR TECHNICIAN (SRT) OBSERVED THE ROLLER PUMP TO FUNCTION PROPERLY THROUGHOUT THE EVALUATION. PER DATA LOG ANALYSIS, THE REPORTED ISSUE OCCURRED ON (B)(6) 2019. ONLY THE FOUR LARGE ROLLER PUMP LOGS WERE AVAILABLE FOR THIS LOG REVIEW. FOR THIS TYPE OF ISSUE THE SYSTEM LOG IS NEEDED FOR A THOROUGH LOG REVIEW. THE FOLLOWING INFORMATION IS BASED ON THE FOUR PUMPS LOGS THAT WERE EXPORTED AT THE MANUFACTURER. THE LAST ENTRIES IN THE LOGS BEFORE BEING RETURNED TO THE MANUFACTURER OCCURRED LAST 11-SEP-2019. THIS DATE WOULD BE RELATIVE TO THE DATE ON THE CENTRAL CONTROL MONITOR (CCM) USED TO EXPORT THE LOGS. IT WAS POSSIBLE THE DATE ON THE CCM WAS NOT SET CORRECTLY CAUSING THE LOG ENTRIES TO HAVE AN INCORRECT DATE, OR THE DATE THE ISSUE OCCURRED WAS REPORTED INCORRECTLY. THE SYSTEM WAS POWERED DOWN AND BACK UP AGAIN AT 8:48:07 AM. THIS TIME ONLY LARGE ROLLER PUMP MODULE ID 02082 HAD NO LOG ENTRIES. THE SYSTEM WAS POWER CYCLED AGAIN AT 9:14:39 AM AND AGAIN ONLY LARGE ROLLER PUMP MODULE ID 02082 HAD NO LOG ENTRIES. THE FIRST ENTRY OCCURRED AT 9:15:50 AM, OVER ONE MINUTE AFTER THE OTHER PUMPS WERE LOGGING EVENTS. IT WAS POSSIBLE THE PUMP CABLE WAS DISCONNECTED AND RECONNECTED TO CAUSE THIS. WITH ONLY THE PUMP LOGS, THERE IS NO WAY TO TELL IF THE MISSING LOG ENTRIES WERE CAUSED BY DISCONNECTION THE PUMP, A FAILURE TO POWER UP, OR POWERING UP WITH AN ERROR. THE PROVIDED LOGS SEEM TO CONFIRM THE COMPLAINT, BUT NOT DEFINITELY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
THE USER FACILITY SENT BACK THE FOLLOWING PRODUCTS FOR EVALUATION: FOUR ROLLER PUMPS (PN: 801041J, SN: (B)(6)), TWO TEMPERATURE PODS (PN: 802114, SN: (B)(6)), ONE PRESSURE POD (PN: 802112, SN: (B)(6)). DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) OBSERVED ALL PRODUCTS TO FUNCTION AS INTENDED EXCEPT FOR ONE TEMPERATURE POD, PN: 802114, SN: (B)(6). HE OBSERVED THE TEMPERATURE POD TO DISPLAY A RED 'X' AND '?' INTERMITTENTLY, AND MICROSCOPIC EXAMINATION REVEALED 12 CHARRED RESISTORS. THE MALFUNCTION OF THE TEMPERATURE POD IS CAPTURED ON THE MEDWATCH REPORT FOR CR-77819. THIS COMPLAINT IS RELATED TO CR-77819 / MEDWATCH #1828100-2020-00181.
PER THE MANUFACTURER'S SUBSIDIARY, THE POWER TO THE AFFECTED PUMP CAME BACK AFTER BEING RECONNECTED. TWO TEMPERATURE MODULES WERE REPLACED AND AS A PRECAUTION, TWO PRESSURE MODULES WERE REPLACED AND ALL FOUR PUMPS WERE REPLACED WITH LOANER PUMPS.
IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP WOULD NOT POWER ON. IN ADDITION, A "X" OR "?" APPEARED OVER THE TEMPERATURE ICON ON THE CENTRAL CONTROL MONITOR (CCM). AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 957460 | ADVANCED PERFUSION SYSTEM 1 | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION | 801763 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |