ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-31156
- Event Type
- Malfunction
- Date Received
- July 5, 2024
- Date of Event
- May 25, 2024
- Report Date
- September 23, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403811012
- PMA / PMN Number
- K133532
- Removal / Correction Number
- Z-2719-2020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
CORRECTION: UNIQUE DEVICE IDENTIFIER (UDI)#. ADDITIONAL INFORMATION: MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. INVESTIGATION SUMMARY: THE REPORTED COMPLAINT THAT THE DRUG PROPOFOL HAD BACK FLOWED UP THE FENTANYL LINE INTO THE SYRINGE AND WAS POOLED ON THE FLOOR WAS NOT CONFIRMED. ¿ FUNCTIONAL TESTING WITH THE SUSPECT SYRINGE MODULE ALONG WITH THE RECEIVED PCU, 50-60ML BD SYRINGE, AND NON-BD SET; ALONG WITH A DCHU PUMP MODULE INFUSING AT THE SAME TIME WHILE CONNECTED TO THE 4-WAY MULTI LUMEN ADAPTOR AND A CVL (CENTRAL VENOUS LINE) OBSERVED NO ISSUE OF LEAKING OR BACK FLOW DURING A NORMAL INFUSION. ¿ INTRODUCING AN OCCLUSION ON THE PATIENT-SIDE LINE PAST THE 4-WAY ADAPTOR CAUSED A BACK FLOW ON THE SYRINGE MODULE LINE; HOWEVER, ONCE THE OCCLUSION WAS RELEASED, THE OBSERVED BACK FLOW WAS PUSHED OUT OF THE LINE. ¿ BACKFLOW WAS ALSO OBSERVED ON THE SYRINGE MODULE LINE WHEN THE DEVICE WAS PAUSED WHILE THE PUMP MODULE LINE WAS INFUSING. CLAMPING THE SYRINGE MODULE LINE WHILE PAUSED AND PUMP MODULE LINE CONTINUED TO INFUSE PREVENTED BACKFLOW TO OCCUR. ¿ THERE WAS NO LEAKING OBSERVED DURING TESTING. ¿ A REVIEW OF THE SUSPECT SYRINGE MODULE AND CONCOMITANT PCU ERROR LOG SHOWED NO ERROR CODE OCCURRED ON THE REPORTED DATE OF (B)(6) 2024. ¿ A REVIEW OF THE CONCOMITANT PCU EVENT LOG OBSERVED THE SUSPECT SYRINGE MODULE BEING POWERED ON WITH THE CONCOMITANT PCU BEGINNING ON (B)(6) 2024 AT 7:16 AM AND WAS ASSIGNED TO CHANNEL ¿B.¿ THE LAST KNOWN INFUSION WITH THE SUSPECT SYRINGE MODULE BEING PROGRAMMED TO INFUSE AT THE REPORTED RATE OF 3.75ML/H WITH THE DRUG FENTANYL BEGINNING ON (B)(6) 2024 7:44 AM. ¿ AT 7:57 AM, A BOLUS DOSE WAS PROGRAMMED WITH THE DOSE BEING 50MCG WHICH INFUSED AT A RATE OF 999ML/HR AND VTBI OF 2.5ML. ¿ AT 10:40 AM, THE SYRINGE MODULE ALARMED FOR ¿SYRINGE CLAMP OPEN¿, THE INFUSION WAS RESTARTED ONE MINUTE AFTER AND WAS CHANNELED OF AT 11:4 AM. ¿ THE CONCOMITANT PUMP MODULE AND CONCOMITANT PCU WERE NOT RECEIVED FOR INVESTIGATION; THEREFORE, THE PARAMETERS THAT WAS INFUSING THE DRUG PROPOFOL AND OTHER ISSUE ON THE PUMP MODULE COULD NOT BE DETERMINED. ¿ THE RETURNED BD 50-60ML SYRINGE, 4-WAY MULTI LUMEN ADAPTOR ON A CVL, AND TERUMO 150CM SF*ET152EL22 SET WERE OBSERVED TO BE IN GOOD CONDITION ¿ THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE PROBABLE CAUSE OF THE REPORTED BACK FLOW IS BEING ATTRIBUTED TO UNCONTROLLED FLUID FLOWING TO THE ADMINISTRATION SET WHILE NOT CLAMPED AND ITS FLUID PATH BLOCKED WHILE UNLOADING THE SYRINGE. LEAKING WAS NOT CONFIRMED DURING THE LABORATORY TESTING. NOTE THAT IMDRF ANNEX A040502, A1801, A0401, A040507, A040601, C23, C0601, D01, D11, G02017, G04061 CODES NOT ASSOCIATED WITH THE ROOT CAUSE BUT IDENTIFIED AS REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING INVESTIGATION ARE UNRELATED TO THE REPORTED ISSUE. THESE OTHER FAILURES PRESUMPTIVELY DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE.
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.
OMIT : B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. CORRECTION: UNIQUE DEVICE IDENTIFIER (UDI)#. ADDED PI TO THE UNIQUE DEVICE IDENTIFIER (UDI)# FIELD. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE EVAL BY MANUFACTURER?, IMDRF ANNEX A, B, C, D, G CODES, REMEDIAL ACTION REQUIRED, REMEDIAL ACTION # AND MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT.
IT WAS REPORTED THAT PROPOFOL WAS INFUSING VIA PUMP ONTO A 4-WAY MULTI-LUMEN ADAPTOR ON A CVL (CENTRAL VENOUS LINE). OTHER INFUSIONS CONNECTED TO THE CVL WERE MAINTENANCE FLUIDS, INSULIN, AND FENTANYL. THE FENTANYL INFUSION WAS RUNNING AT 3.75ML/HR. BEDSIDE NURSE REPORTEDLY NOTICED THAT PROPOFOL "HAD BACK TRACKED (BACK FLOWED) UP THE FENTANYL LINE INTO THE SYRINGE AND WAS POOLED ON THE FLOOR". THE CVL WAS THE FLUSHED AND THERE WAS "NO RESISTANCE". THE LINE ATTACHED TO FENTANYL SYRINGE WAS CHECKED, IT WAS "NOT CROSS THREADED OR LOOSE". THE CLINICIAN WAS "UNSURE WHERE THE PROPOFOL HAD LEAKED ONTO THE FLOOR FROM". PER REPORT, A "MIXTURE OF BLOOD AND PROPOFOL WAS FOUND ON THE FLOOR SHORTLY AFTER THE START OF THE SHIFT". THE PROPOFOL BOTTLE AND LINE WAS THEN CHANGED (AT AROUND 0800HRS). FOR THE PURPOSE OF AN INCIDENT INVESTIGATION, THE SYRINGE HAS BEEN EMPTIED OF FENTANYL AND REPLACED WITH WATER, ACCORDING TO THE CUSTOMER. THE SYRINGE LABEL HAS BEEN DE-IDENTIFIED, THE LUMEN OF THE MULTI-LUMEN ADAPTOR WHICH THE PROPOFOL WAS ATTACHED TO HAS BEEN MARKED WITH A "RED BUNG" AND A PROPOFOL LABEL. THERE WAS NO PROPOFOL BACKTRACKED INTO THE INSULIN LINE AND THE MAINTENANCE LINE HAS AN "ANTI-REFLUX VALVE". AS THE FENTANYL WAS RUNNING, THE PUMP REPORTEDLY "SHOULD HAVE BEEN UNDER POSITIVE PRESSURE AND THE PROPOFOL SHOULD NOT HAVE BEEN ABLE TO BACKTRACK INTO THE SYRINGE". THE PATIENT BECAME MUCH MORE SEDATED (DESIRED OUTCOME) AFTER SETTING UP NEW PUMPS AND MOVING THE PROPOFOL TO A SPARE CVL LUMEN. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. BD HAS RECEIVED ADDITIONAL INFORMATION. IT WAS REPORTED THAT THE EVENT OCCURRED ON 25 MAY 2024 ¿ AROUND 8-11AM. THE FOLLOWING WERE THE TUBING SETS USED: - TUBING FOR PROPOFOL: BD ALARIS PUMP INFUSION SET 2420-0007 - TUBING FOR MAINTENANCE FLUIDS: BD ALARIS PUMP INFUSION SET 2420-0007 - TUBING FOR INSULIN: TERUMO 150CM SF*ET152EL22 - TUBING FOR FENTANYL" TERUMO 150CM SF*ET152EL22.
IT WAS REPORTED THAT PROPOFOL WAS INFUSING VIA PUMP ONTO A 4-WAY MULTI-LUMEN ADAPTOR ON A CVL (CENTRAL VENOUS LINE). OTHER INFUSIONS CONNECTED TO THE CVL WERE MAINTENANCE FLUIDS, INSULIN, AND FENTANYL. THE FENTANYL INFUSION WAS RUNNING AT 3.75ML/HR. BEDSIDE NURSE REPORTEDLY NOTICED THAT PROPOFOL "HAD BACK TRACKED (BACK FLOWED) UP THE FENTANYL LINE INTO THE SYRINGE AND WAS POOLED ON THE FLOOR". THE CVL WAS THE FLUSHED AND THERE WAS "NO RESISTANCE". THE LINE ATTACHED TO FENTANYL SYRINGE WAS CHECKED, IT WAS "NOT CROSS THREADED OR LOOSE". THE CLINICIAN WAS "UNSURE WHERE THE PROPOFOL HAD LEAKED ONTO THE FLOOR FROM". PER REPORT, A "MIXTURE OF BLOOD AND PROPOFOL WAS FOUND ON THE FLOOR SHORTLY AFTER THE START OF THE SHIFT". THE PROPOFOL BOTTLE AND LINE WAS THEN CHANGED (AT AROUND 0800HRS). FOR THE PURPOSE OF AN INCIDENT INVESTIGATION, THE SYRINGE HAS BEEN EMPTIED OF FENTANYL AND REPLACED WITH WATER, ACCORDING TO THE CUSTOMER. THE SYRINGE LABEL HAS BEEN DE-IDENTIFIED, THE LUMEN OF THE MULTI-LUMEN ADAPTOR WHICH THE PROPOFOL WAS ATTACHED TO HAS BEEN MARKED WITH A "RED BUNG" AND A PROPOFOL LABEL. THERE WAS NO PROPOFOL BACKTRACKED INTO THE INSULIN LINE AND THE MAINTENANCE LINE HAS AN "ANTI-REFLUX VALVE". AS THE FENTANYL WAS RUNNING, THE PUMP REPORTEDLY "SHOULD HAVE BEEN UNDER POSITIVE PRESSURE AND THE PROPOFOL SHOULD NOT HAVE BEEN ABLE TO BACKTRACK INTO THE SYRINGE". THE PATIENT BECAME MUCH MORE SEDATED (DESIRED OUTCOME) AFTER SETTING UP NEW PUMPS AND MOVING THE PROPOFOL TO A SPARE CVL LUMEN. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. BD HAS RECEIVED ADDITIONAL INFORMATION. IT WAS REPORTED THAT THE EVENT OCCURRED ON 25 MAY 2024 ¿ AROUND 8-11AM. THE FOLLOWING WERE THE TUBING SETS USED: - TUBING FOR PROPOFOL: BD ALARIS PUMP INFUSION SET 2420-0007 - TUBING FOR MAINTENANCE FLUIDS: BD ALARIS PUMP INFUSION SET 2420-0007 - TUBING FOR INSULIN: TERUMO 150CM SF*ET152EL22 - TUBING FOR FENTANYL" TERUMO 150CM SF*ET152EL22.
IT WAS REPORTED THAT PROPOFOL WAS INFUSING VIA PUMP ONTO A 4-WAY MULTI-LUMEN ADAPTOR ON A CVL (CENTRAL VENOUS LINE). OTHER INFUSIONS CONNECTED TO THE CVL WERE MAINTENANCE FLUIDS, INSULIN, AND FENTANYL. THE FENTANYL INFUSION WAS RUNNING AT 3.75ML/HR. BEDSIDE NURSE REPORTEDLY NOTICED THAT PROPOFOL "HAD BACK TRACKED (BACK FLOWED) UP THE FENTANYL LINE INTO THE SYRINGE AND WAS POOLED ON THE FLOOR". THE CVL WAS THE FLUSHED AND THERE WAS "NO RESISTANCE". THE LINE ATTACHED TO FENTANYL SYRINGE WAS CHECKED, IT WAS "NOT CROSS THREADED OR LOOSE". THE CLINICIAN WAS "UNSURE WHERE THE PROPOFOL HAD LEAKED ONTO THE FLOOR FROM". PER REPORT, A "MIXTURE OF BLOOD AND PROPOFOL WAS FOUND ON THE FLOOR SHORTLY AFTER THE START OF THE SHIFT". THE PROPOFOL BOTTLE AND LINE WAS THEN CHANGED (AT AROUND 0800HRS). FOR THE PURPOSE OF AN INCIDENT INVESTIGATION, THE SYRINGE HAS BEEN EMPTIED OF FENTANYL AND REPLACED WITH WATER, ACCORDING TO THE CUSTOMER. THE SYRINGE LABEL HAS BEEN DE-IDENTIFIED, THE LUMEN OF THE MULTI-LUMEN ADAPTOR WHICH THE PROPOFOL WAS ATTACHED TO HAS BEEN MARKED WITH A "RED BUNG" AND A PROPOFOL LABEL. THERE WAS NO PROPOFOL BACKTRACKED INTO THE INSULIN LINE AND THE MAINTENANCE LINE HAS AN "ANTI-REFLUX VALVE". AS THE FENTANYL WAS RUNNING, THE PUMP REPORTEDLY "SHOULD HAVE BEEN UNDER POSITIVE PRESSURE AND THE PROPOFOL SHOULD NOT HAVE BEEN ABLE TO BACKTRACK INTO THE SYRINGE". THE PATIENT BECAME MUCH MORE SEDATED (DESIRED OUTCOME) AFTER SETTING UP NEW PUMPS AND MOVING THE PROPOFOL TO A SPARE CVL LUMEN. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. BD HAS RECEIVED ADDITIONAL INFORMATION. IT WAS REPORTED THAT THE EVENT OCCURRED ON (B)(6) 2024 ¿ AROUND 8-11AM. THE FOLLOWING WERE THE TUBING SETS USED: TUBING FOR PROPOFOL: BD ALARIS PUMP INFUSION SET 2420-0007. TUBING FOR MAINTENANCE FLUIDS: BD ALARIS PUMP INFUSION SET 2420-0007. TUBING FOR INSULIN: TERUMO 150CM SF*ET152EL22. TUBING FOR FENTANYL" TERUMO 150CM SF*ET152EL22.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447973 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8110 | 10885403811012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015.| 8110. |