PLUM 360 DRIVER NEW
Report
- Report Number
- 9615050-2024-00335
- Event Type
- Death
- Date Received
- April 26, 2024
- Date of Event
- March 19, 2024
- Report Date
- September 17, 2024
- Manufacturer
- ICU MEDICAL COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K141789
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE OTHER ICU MEDICAL PLUM 360 DRIVER NEW PUMPS THAT WERE CONNECTED TO THE PATIENT WHEN THE EVENT OCCURRED ARE THE FOLLOWING: (B)(6) SERIAL#: (B)(6) - INFUSING DEXMEDETOMIDINE. (B)(6) SERIAL#: (B)(6) - INFUSING KETAMINE AND NORMAL SALINE. (B)(6) SERIAL#: (B)(6) - INFUSING FENTANYL AND NORMAL SALINE. (B)(6) SERIAL#: (B)(6) - INFUSING AMIODARONE. (B)(6) SERIAL#: (B)(6) - INFUSING ARGATROBAN. THE G8 - MFR REPORT# FOR EACH PUMP ABOVE WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. THE DEVICE IS EXPECTED TO BE RECEIVED FOR EVALUATION- IT IS NOT YET RECEIVED.
D4 - PRIMARY UDI NUMBER - (B)(4). D9 - DATE RETURNED TO MFG - 27 APR 2024. INVESTIGATION SUMMARY PUMP EVALUATION: ON APRIL 29, 2024, ICU MEDICAL SERVICE DOWNLOADED THE CDA LOGS FROM DEVICE SERIAL NUMBER (B)(6) (LIST NUMBER 30010-04-05) AND SENT THEM TO R&D FOR ANALYSIS. THIS WAS ONE OF THE 6 DEVICES INVOLVED IN THE EVENT. THE DEVICE WAS RECEIVED WITH SOFTWARE VERSION 15.20.1.8 INSTALLED. ICU MEDICAL SERVICE PLUGGED THE DEVICE INTO AC POWER AND OBSERVED THAT THE AC POWER LIGHT ILLUMINATED, INDICATING THAT THE DEVICE WAS RECEIVING AC POWER AND CHARGING THE BATTERY. THE ORIGINAL DEVICE BATTERY, A PANASONIC, WAS RECHARGED FOR A MINIMUM OF 8 HOURS. ACCORDING TO THE TECHNICAL SERVICE MANUAL (TSM), THE TYPICAL OPERATING TIME FOR A NEW AND FULLY CHARGED BATTERY IS 7 HOURS WHEN INFUSING AT A RATE OF 25 ML/HR. AFTER THE BATTERY WAS FULLY RECHARGED, ICU MEDICAL SERVICE PROGRAMMED THE DEVICE TO OPERATE FOR THE TYPICAL DURATION EXPECTED FOR A NEW AND FULLY CHARGED BATTERY. HOWEVER, THE DEVICE FELL SHORT OF THE 7-HOUR MARK BY 12 MINUTES, INFUSING FOR A TOTAL OF 6 HOURS AND 48 MINUTES UNTIL THE BATTERY WAS DEPLETED. THE DEVICE POWERED OFF CORRECTLY AND DID NOT RECORD A PREVIOUS ABNORMAL SHUTDOWN. THIS SUGGESTS THAT WHILE THE BATTERY'S PERFORMANCE WAS SLIGHTLY BELOW THE TYPICAL OPERATING TIME, THE DEVICE'S POWER MANAGEMENT SYSTEM IS FUNCTIONING CORRECTLY. AFTER REVIEWING THE ICU SERVICE RECORDS: IT WAS FOUND THAT THE BATTERY WAS NOT REPLACED BY ICU MEDICAL. THE PANASONIC BATTERY INSTALLED ON THE PUMP WAS NOT THE ORIGINAL ONE FROM THE MANUFACTURING IN 2016, AS THE ORIGINAL HAD THE LOT NUMBER 151211A. THE REPLACEMENT BATTERY ON THE PUMP HAD THE LOT NUMBER 201020A, WHICH INDICATES THAT IT WAS REPLACED BY THE CUSTOMER AND WAS 2 OR MORE YEARS OLD. AS PER TSM, IT IS RECOMMENDED THAT THE SEALED LEAD-ACID BATTERY BE REPLACED EVERY TWO (2) YEARS. MORE FREQUENT REPLACEMENT IS SUGGESTED IN HEAVY BATTERY-USE ENVIRONMENTS. THIS IS INDICATED WHEN A "REPLACE BATTERY" ERROR OR OTHER BATTERY-RELATED ERROR CODES ARE OBSERVED. THIS COULD BE THE PROBABLE CAUSE OF THE CUSTOMER-REPORTED ISSUE OF THE DEVICE SHUTTING OFF ON BATTERY (DC) POWER. HOWEVER, ICU MEDICAL SERVICE COULD NOT CONFIRM THE CUSTOMER-REPORTED ISSUES OF THE DEVICE SHUTTING DOWN ON AC POWER OR EXPERIENCING A "WARNING CHARGER SERVICE". THERE WAS NO EVIDENCE OF THE DEVICE ALARMING WITH ANY CHARGER SERVICE ERROR ALARMS. WE COULD NOT CONFIRM THE CUSTOMER¿S COMPLAINT OF THE DEVICE NOT AUDIBLY ALARMING WITH LOW BATTERY OR DEPLETED BATTERY BEFORE SHUTTING DOWN. THE DEVICE PASSED THE ALARM LOUDNESS PVT TEST AND AUDIBLY ALARMS WITH BOTH LOW BATTERY AND DEPLETED BATTERY BEFORE POWERING DOWN. DURING INSPECTION, ICU MEDICAL SERVICE FOUND THAT THE DEVICE WAS RECEIVED WITH A NON-ICU-APPROVED ENCLOSURE AND AN INCORRECT DRIVER PID LABEL. THE FRONT ENCLOSURE AND PERIPHERAL COVER WERE DAMAGED. ICU MEDICAL SERVICE VERIFIED THESE DISCREPANCIES THROUGH VISUAL INSPECTION. THESE CONDITIONS ARE UNRELATED TO THE REPORTED EVENT. ICU MEDICAL SERVICE REACHED OUT TO TSC (TECH SUPPORT CENTER) TO OBTAIN AN ENHANCED SERVICE FEE TO REPLACE AND EVALUATE THE DEVICE WITH NON-OEM PARTS, AND TO BRING THE DEVICE BACK TO OEM STANDARDS. NO REPAIRS HAVE BEEN CONDUCTED AT THIS TIME. R&D EVENT LOG ANALYSIS: 19/03/2024: 05:33:31 = LINE A: STANDBY STOPPED BY USER (RESUMING INFUSION). 05:33:39 = LINE A: PLACED IN STANDBY MODE. 06:52:23 = POWER UPDATE: POWER SWITCHED TO BATTERY. 07:38:06 = USER USED ¿SETTINGS/VOLS/CCCA¿ SCREEN TO ADJUST SCREEN LIGHTING & CONTRAST. 08:34:23 = POWER UPDATE: POWER SWITCHED TO AC MAIN. 09:50:26 = POWER UPDATE: POWER SWITCHED TO BATTERY. 10:31:17 = POWER UPDATE: POWER SWITCHED TO AC MAIN. 10:52:43 = LINE A: INFUSION MANUALLY STOPPED (BY USER PRESSING [STOP] BUTTON). 10:52:45 = POWER UPDATE: PUMP POWERED OFF (BY USER PRESSING [ON_OFF]). 11:06:10 = POWER UPDATE: POWER SWITCHED TO BATTERY. 11:14:11 = POWER UPDATE: PUMP POWERED ON (BY USER PRESSING [ON_OFF]). CURRENTLY ON BATTERY POWER. (NOTE: LOGGING TIME DELAYED DUE TO PUMP CE PROCESSOR BOOTING FOR POWER ON. INFERRED ACTUAL KEYPRESS TIME ESTIMATED AS 11:12:58 BASED ON FOLLOWING ALARM.). 11:14:58 = INFUSER IDLE 2 MINUTES ALARM. 11:25:15 = INFUSER IDLE 2 MINUTES ALARM CLEARED BY PRESSING THE [STOP] BUTTON. 11:27:11 = POWER UPDATE: PUMP POWERED OFF (BY USER PRESSING [ON_OFF]). MARCH 20, 2024: 08:42:38 = POWER UPDATE: PUMP POWERED ON (BY USER PRESSING [ON_OFF]). CURRENTLY ON BATTERY POWER. ENGINEERING SUMMARIZES FINDINGS: SERIAL NUMBER: (B)(6). BY MAR 19TH, THERE WAS NO SERVICE CHARGER ALARM, AND THE DEVICE WAS CONNECTED TO AC MAIN FROM 10:31 TO 10:52 WHEN IT WAS POWERED OFF AND GOT SWITCHED TO BATTERY. ENGINEERING EVALUATES THAT: SERIAL NUMBER: (B)(6): ENGINEERING EVALUATES THAT THE DEVICE DID NOT ISSUE ANY SERVICE CHARGER/REPLACE BATTERY ALARM AND THERE WAS NO SWITCH TO BATTERY IN THE MENTIONED TIME FRAME OF 10:33 TO 10:37. THERE WERE NO INDICATIONS, EITHER IN THE CLINICAL OR THE DIAGNOSTIC LOGS, THE PUMP EVER SHUT OFF ON MARCH 19 EXCEPT WHEN COMMANDED BY THE USER PRESSING [ON_OFF]. ENGINEERING COULDN¿T CONFIRM THE CUSTOMER¿S REPORT OF THE PUMP SHUTTING OFF WITHOUT AUDIBLE ALARM. BASED ON THE OCCURRENCE OF ¿WARNING CHARGER SERVICE¿ AND ¿WARNING REPLACE BATTERY¿ ALARMS, ENGINEERING RECOMMENDS SERVICE CENTER EVALUATE THE POWER SYSTEMS (INCLUDING BATTERIES) BEFORE THE PUMP IS RETURNED TO CUSTOMER.
THE EVENT INVOLVED A PLUM 360 PUMP WHERE THE CUSTOMER REPORTED THAT IT SWITCHED TO BATTERY THEN SHUT OFF. THE NURSE CALLED FOR A NEW PACK OF PUMP STAT FOR CVICU B702 AS THE PUMP CRASHED AT ONCE, THE PATIENT WAS IN CARDIOGENIC SHOCK AND WAS ON MULTIPLE INFUSIONS. THE NURSE INDICATED THAT THE PUMP LOST INTEGRATION AND TURNED ITSELF OFF. IT WAS ADDED THAT IN THE MAR REPORT SEVERAL MEDICATIONS WERE RESTARTED AT THE END OF THE 10AM HOUR WHICH CORRELATES WITH THE DISASSOCIATION TIMES. THE PUMP WAS INFUSING WITH NOREPINEPHRINE AND NORMAL SALINE (NSS) WITH ORDER#: (B)(4), IT WAS COMPOUNDED. THE MANUFACTURER FOR NOREPINEPHRINE WAS CIVICA, INC. WITH NDC#: 72572-481-01 AND THE MANUFACTURER FOR NSS WAS BAXTER HEALTHCA WITH NDC#: 0338-0049-02. THE CONCENTRATION WAS 16 MG/250 ML ROUTED TO IV LINE A, PUMP SETTING WAS ON STANDBY AND ORDER SETTING WAS 0 ML/HR. THE DEVICE WAS PROGRAMMED PUMP - STOPPED ON (B)(6) 2024 0533. DEVICE HISTORY LOG HAS BEEN PROVIDED; THE EVENT HAPPENED AT 10:33 ¿ PARAMETER: 43695, ALARM DESCRIPTION: WARNING: CHARGER SERVICE. THE ROW THAT IS HIGHLIGHTED RED DID NOT HAVE THE ¿WARNING: CHARGER SERVICE¿ ALARM BUT DID HAVE MULTIPLE WARNINGS IN THE MORNING TO REPLACE THE BATTERY. AT 10:32 IT SWITCHED POWER TO BATTERY AND THEN BACK TO AC BETWEEN 10:32:50 AM AND 10:32:51 AM. THE PUMP DID NOT SOUND AN AUDIBLE TONE PRIOR POWERING OFF AND ALARM MESSAGE NOTED ON THE DISPLAY. THERE WAS PATIENT HARM AS THE CRITICAL INFUSIONS WAS STOPPED ABRUPTLY, THE PATIENT WAS UNSTABLE. THERE WAS A DELAY IN THERAPY AS THE CRITICAL INFUSIONS STOPPED ABRUPTLY. MEDICAL INTERVENTION WAS REQUIRED, THE PATIENT SHOCKED OUT OF VENTRICULAR TACHYCARDIA LATER THAT AFTERNOON. THE PATIENT WAS CRITICALLY ILL IN CARDIOVASCULAR INTENSIVE CARE WITH CARDIOGENIC SHOCK. THE PUMP WAS ON A LARGE POLE WITH A POWER STRIP AND THE POWER STRIP WAS PLUGGED INTO THE WALL (AC POWER). IT IS UNKNOWN IF THE CHARGE INDICATOR LIGHTS UP WHEN THE DEVICE WAS PLUGGED INTO AC POWER. THE PATIENT EXPIRED AND IS CAPTURED UNDER THIS RECORD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 886489 | PLUM 360 DRIVER NEW | PUMP, INFUSION | FRN | ICU MEDICAL COSTA RICA LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death | NOREPINEPHRINE, CIVICA, INC W/ NDC # 72572-481-01.| NORMAL SALINE, BAXTER HC W/ NDC # 0338-0049-02. |