ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-38221
- Event Type
- Injury
- Date Received
- October 7, 2024
- Date of Event
- August 14, 2024
- Report Date
- November 28, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- PMA / PMN Number
- K012383
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.
ADDITIONAL INFORMATION: MANUFACTURER NARRATIVE. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED ISSUE OF "CASSETTE JAMMED ERROR" WAS NOT DETERMINED BECAUSE NO PRODUCTS OR DEVICE LOGS WERE RETURNED. THE CUSTOMER HAS NOT RESPONDED TO THE MULTIPLE COMMUNICATIONS BY THE MANUFACTURER REQUESTING FOR ADDITIONAL INFORMATION AND PRODUCT RETURN.
A COPY OF THE MEDWATCH REPORT FROM FDA WAS RECEIVED, WHICH STATES, ¿(B)(6) WAS REQUESTED TO (B)(6) HOSPITAL FOR A TRANSFER TO (B)(6) MEDICAL CENTER. THE REGISTERED NURSE'S PHONE REPORT INDICATES THE PATIENT IS A 62-YEAR-OLD FEMALE WHO CONSUMED AN ENTIRE BAG OF THC GUMMIES. SHE WAS BROUGHT TO OBH VIA POV (PRIVATELY OWNED VEHICLE) IN AN UNRESPONSIVE STATE AND SUBSEQUENTLY EXHIBITED SIGNS OF RESPIRATORY FAILURE. THE PATIENT WAS INTUBATED, PLACED ON SEDATION, AND STARTED ON PRESSOR INFUSIONS. SHE IS NOW BEING TRANSFERRED TO (B)(6) ICU FOR FURTHER CARE UPON THEIR ARRIVAL, PARAMEDIC (B)(6) REMAINED AT THE NURSING STATION TO HANDLE REPORT AND PAPERWORK, WHILE PARAMEDIC (B)(6) AND PARAMEDIC (B)(6) PROCEEDED TO THE PATIENT'S BEDSIDE. ONCE THERE, (B)(6) AND (B)(6) IMMEDIATELY BEGAN THE ASSESSMENT AND TRANSFER OF EQUIPMENT. (B)(6) FOCUSED ON THE LEVOPHED INFUSION WHILE I PREPARED THE CARDIAC MONITORING EQUIPMENT (THE PATIENT WAS STILL ON OBH EQUIPMENT AT THIS TIME). DUE TO THE NEED FOR NEW TUBING, THE LEVOPHED INFUSION HAD TO BE STOPPED, RE-SPIKED, PRIMED, AND THEN PLACED ON OUR INFUSION PUMP. (B)(6) HAD THE CALCULATIONS READY IN THE PUMP, BUT WHEN THE INFUSION STARTED, WE RECEIVED A 'CASSETTE JAMMED' ERROR. THEY ATTEMPTED TO TROUBLESHOOT BY REMOVING AND REINSTALLING THE CASSETTE MULTIPLE TIMES ACROSS DIFFERENT CHANNELS (A & B), BUT THE ERROR PERSISTED. THEY DECIDED TO REPLACE IT WITH TUBING FROM THE AIRCRAFT, WHICH WAS THE ORIGINAL MANUFACTURER PUMP TUBING USED PRIOR TO THE RECENT SHORTAGE. I RETRIEVED THE ORIGINAL MANUFACTURER TUBING FROM THE AIRCRAFT, AND UPON RETURNING TO THE ROOM, NOTED THAT THE PATIENT HAD BECOME SIGNIFICANTLY HYPOTENSIVE. (B)(6) AND (B)(6) WERE WORKING TO TRANSFER THE SEDATION INFUSIONS, BUT QUICKLY FOCUSED ON REESTABLISHING THE LEVOPHED INFUSION. DURING THIS TIME, THE PATIENT EXPERIENCED SIGNIFICANT HYPOTENSION AND EPISODES OF BRADYCARDIA HR (HEART RATE) DROPPED FROM THE 50S TO THE UPPER 30S, STILL ON OBH'S CARDIAC MONITOR). ONCE THE LEVOPHED INFUSION WAS RESTORED, (B)(6) INCREASED THE RATE TO STABILIZE THE PATIENT'S BLOOD PRESSURE, AND UPON ACHIEVING NORMOTENSIVE PRESSURES, THE LEVOPHED WAS RETURNED TO ITS INITIAL STARTING DOSE. THE TWO REMAINING INFUSIONS, VERSED AND FENTANYL, ALSO PRESENTED CHALLENGES, RESULTING IN ERRORS SUCH AS 'CASSETTE JAM' OR 'FLUID SIDE.' AFTER SOME TROUBLESHOOTING, WE WERE ABLE TO RESOLVE THESE ISSUES WITHOUT FURTHER ADVERSE EFFECTS. THE FENTANYL INFUSION ENCOUNTERED ONLY MINOR ISSUES (AIR SENSOR) THAT WERE EASILY ADDRESSED. HOWEVER, THE VERSED INFUSION CONTINUED TO DISPLAY A 'CASSETTE JAM' ERROR. AT THIS POINT, THEY HAD EXHAUSTED OUR SUPPLY OF 'ORIGINAL TUBING' AND HAD TO REVERT TO THE NEWEST TUBING PRODUCED BY ENVIHS (ENVI HEALTH SOLUTIONS). (B)(6) EVENTUALLY MANAGED TO GET THE INFUSION RUNNING WITH THE NEW TUBING, BUT IT REPEATEDLY DISPLAYED A 'CHANNEL SERVICE' ERROR AND WOULD STOP INFUSING EVERY 2-4 MINUTES. THEY MANAGED TO WORK AROUND THIS BY SELECTING THE CHANNEL, PRESSING THE 'RETRY' BUTTON, AND RESTARTING THE INFUSION. HOWEVER, UPON THEIR ARRIVAL AT (B)(6), THE CHANNEL COMPLETELY LOCKED OUT, INDICATING 'SERVICE,' AND WOULD NO LONGER INFUSE. WHILE THERE WERE NO ADVERSE REACTIONS OR OUTCOMES DUE TO THESE INFUSION PUMP AND TUBING ISSUES, THE SITUATION COULD HAVE BEEN CATASTROPHIC. THROUGHOUT THIS PROCESS, IT IS ESTIMATED THAT THE PATIENT WAS OFF THE LEVOPHED INFUSION FOR APPROXIMATELY 10 MINUTES. HOWEVER, THE TOTAL DELAY ON SCENE DUE TO PUMP AND TUBING MALFUNCTIONS WAS SIGNIFICANTLY LONGER, ESTIMATED TO BE AROUND 35-40 MINUTES. WE UTILIZE THE ALARIS MEDSYSTEM 3 AND PUMP TUBING FROM ENVI HEALTH SOLUTIONS. REF REPORT: MW5158593.¿ THE CUSTOMER HAS NOT RESPONDED TO THE MULTIPLE COMMUNICATIONS BY THE MANUFACTURER REQUESTING FOR ADDITIONAL INFORMATION AND PRODUCT RETURN.
A COPY OF THE MEDWATCH REPORT FROM FDA WAS RECEIVED, WHICH STATES, ¿(B)(6) WAS REQUESTED TO (B)(6) HOSPITAL FOR A TRANSFER TO (B)(6) MEDICAL CENTER. THE REGISTERED NURSE'S PHONE REPORT INDICATES THE PATIENT IS A 62-YEAR-OLD FEMALE WHO CONSUMED AN ENTIRE BAG OF THC GUMMIES. SHE WAS BROUGHT TO OBH VIA POV (PRIVATELY OWNED VEHICLE) IN AN UNRESPONSIVE STATE AND SUBSEQUENTLY EXHIBITED SIGNS OF RESPIRATORY FAILURE. THE PATIENT WAS INTUBATED, PLACED ON SEDATION, AND STARTED ON PRESSOR INFUSIONS. SHE IS NOW BEING TRANSFERRED TO (B)(6) ICU FOR FURTHER CARE UPON THEIR ARRIVAL, PARAMEDIC (B)(6) REMAINED AT THE NURSING STATION TO HANDLE REPORT AND PAPERWORK, WHILE PARAMEDIC (B)(6) AND PARAMEDIC (B)(6) PROCEEDED TO THE PATIENT'S BEDSIDE. ONCE THERE, (B)(6) AND (B)(6) IMMEDIATELY BEGAN THE ASSESSMENT AND TRANSFER OF EQUIPMENT. (B)(6) FOCUSED ON THE LEVOPHED INFUSION WHILE I PREPARED THE CARDIAC MONITORING EQUIPMENT (THE PATIENT WAS STILL ON OBH EQUIPMENT AT THIS TIME). DUE TO THE NEED FOR NEW TUBING, THE LEVOPHED INFUSION HAD TO BE STOPPED, RE-SPIKED, PRIMED, AND THEN PLACED ON OUR INFUSION PUMP. (B)(6) HAD THE CALCULATIONS READY IN THE PUMP, BUT WHEN THE INFUSION STARTED, WE RECEIVED A 'CASSETTE JAMMED' ERROR. THEY ATTEMPTED TO TROUBLESHOOT BY REMOVING AND REINSTALLING THE CASSETTE MULTIPLE TIMES ACROSS DIFFERENT CHANNELS (A & B), BUT THE ERROR PERSISTED. THEY DECIDED TO REPLACE IT WITH TUBING FROM THE AIRCRAFT, WHICH WAS THE ORIGINAL MANUFACTURER PUMP TUBING USED PRIOR TO THE RECENT SHORTAGE. I RETRIEVED THE ORIGINAL MANUFACTURER TUBING FROM THE AIRCRAFT, AND UPON RETURNING TO THE ROOM, NOTED THAT THE PATIENT HAD BECOME SIGNIFICANTLY HYPOTENSIVE. (B)(6) AND (B)(6) WERE WORKING TO TRANSFER THE SEDATION INFUSIONS, BUT QUICKLY FOCUSED ON REESTABLISHING THE LEVOPHED INFUSION. DURING THIS TIME, THE PATIENT EXPERIENCED SIGNIFICANT HYPOTENSION AND EPISODES OF BRADYCARDIA HR (HEART RATE) DROPPED FROM THE 50S TO THE UPPER 30S, STILL ON OBH'S CARDIAC MONITOR). ONCE THE LEVOPHED INFUSION WAS RESTORED, (B)(6) INCREASED THE RATE TO STABILIZE THE PATIENT'S BLOOD PRESSURE, AND UPON ACHIEVING NORMOTENSIVE PRESSURES, THE LEVOPHED WAS RETURNED TO ITS INITIAL STARTING DOSE. THE TWO REMAINING INFUSIONS, VERSED AND FENTANYL, ALSO PRESENTED CHALLENGES, RESULTING IN ERRORS SUCH AS 'CASSETTE JAM' OR 'FLUID SIDE.' AFTER SOME TROUBLESHOOTING, WE WERE ABLE TO RESOLVE THESE ISSUES WITHOUT FURTHER ADVERSE EFFECTS. THE FENTANYL INFUSION ENCOUNTERED ONLY MINOR ISSUES (AIR SENSOR) THAT WERE EASILY ADDRESSED. HOWEVER, THE VERSED INFUSION CONTINUED TO DISPLAY A 'CASSETTE JAM' ERROR. AT THIS POINT, THEY HAD EXHAUSTED OUR SUPPLY OF 'ORIGINAL TUBING' AND HAD TO REVERT TO THE NEWEST TUBING PRODUCED BY ENVIHS (ENVI HEALTH SOLUTIONS). (B)(6) EVENTUALLY MANAGED TO GET THE INFUSION RUNNING WITH THE NEW TUBING, BUT IT REPEATEDLY DISPLAYED A 'CHANNEL SERVICE' ERROR AND WOULD STOP INFUSING EVERY 2-4 MINUTES. THEY MANAGED TO WORK AROUND THIS BY SELECTING THE CHANNEL, PRESSING THE 'RETRY' BUTTON, AND RESTARTING THE INFUSION. HOWEVER, UPON THEIR ARRIVAL AT (B)(6), THE CHANNEL COMPLETELY LOCKED OUT, INDICATING 'SERVICE,' AND WOULD NO LONGER INFUSE. WHILE THERE WERE NO ADVERSE REACTIONS OR OUTCOMES DUE TO THESE INFUSION PUMP AND TUBING ISSUES, THE SITUATION COULD HAVE BEEN CATASTROPHIC. THROUGHOUT THIS PROCESS, IT IS ESTIMATED THAT THE PATIENT WAS OFF THE LEVOPHED INFUSION FOR APPROXIMATELY 10 MINUTES. HOWEVER, THE TOTAL DELAY ON SCENE DUE TO PUMP AND TUBING MALFUNCTIONS WAS SIGNIFICANTLY LONGER, ESTIMATED TO BE AROUND 35-40 MINUTES. WE UTILIZE THE ALARIS MEDSYSTEM 3 AND PUMP TUBING FROM ENVI HEALTH SOLUTIONS. REF REPORT: MW5158593.¿ THE CUSTOMER HAS NOT RESPONDED TO THE MULTIPLE COMMUNICATIONS BY THE MANUFACTURER REQUESTING FOR ADDITIONAL INFORMATION AND PRODUCT RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2585759 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | Required Intervention |