ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-34251
- Event Type
- Malfunction
- Date Received
- August 21, 2024
- Date of Event
- July 26, 2024
- Report Date
- November 7, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
OMIT: CONCOMITANT MED PROD DATA (8100), C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. ADDITIONAL INFORMATION: IMDRF ANNEX A,G,B,C AND D CODES AND MANUFACTURER NARRATIVE. THE ACTUAL DATE OF EVENT IS UNKNOWN. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED UNDER INFUSION COULD NOT BE DETERMINED AND NO DEVICES WERE RETURNED FOR TESTING OR ANALYSIS.
CORRECTION: DESCRIBE EVENT OR PROBLEM ADDITIONAL INFORMATION: MANUFACTURER NARRATIVE INVESTIGATION SUMMARY: THE REPORTED EVENT OF UNDER INFUSION COULD NOT BE REPLICATED DUE TO NO DEVICES BEING RECEIVED FOR INVESTIGATION. ¿ NO LABORATORY TESTING OR LOG ANALYSIS WAS ABLE TO BE PERFORMED ON THE REPORTED DEVICES AS IT WAS NOT RETURNED FOR INVESTIGATION. ¿ FOR THE CORRECT SETUP OF THE SECONDARY INFUSION, FOLLOW THE INSTRUCTIONS IN THE ALARIS SYSTEM USER MANUAL V12.3. ¿ HERE ARE SOME SUGGESTIONS FOR THE SECONDARY INFUSION SETUP: ¿ THE SECONDARY ADMINISTRATION SET MUST BE PRIMED PRIOR TO BEGINNING THE SECONDARY INFUSION. ¿ THE SECONDARY SOLUTION CONTAINER MUST BE HIGHER THAN THE PRIMARY SOLUTION CONTAINER. ¿ SECONDARY APPLICATIONS REQUIRE THE USE OF A CHECK VALVE OR CLAMP ON THE PRIMARY IV LINE TO PREVENT BACKFLOW OF SECONDARY MEDICATION INTO THE PRIMARY LINE. ¿ THE CLAMP ON THE SECONDARY ADMINISTRATION SET MUST BE OPENED. IF THE CLAMP IS NOT OPENED, THE FLUID IS DELIVERED FROM THE PRIMARY CONTAINER. ¿ THE SECONDARY VTBI SETTINGS REQUIRE CONSIDERATION OF SUCH VARIABLES AS FACTORY OVERFILL, MEDICATION ADDITIONS. ¿ UNDERESTIMATING THE VOLUME CAUSES THE REMAINING SECONDARY SOLUTION TO BE INFUSED AT THE PRIMARY RATE, OVERESTIMATING RESULTS IN THE PRIMARY SOLUTION BEING INFUSED AT THE SECONDARY RATE. MULTIPLE DOSES FROM A SINGLE CONTAINER ARE NOT POSSIBLE. ¿ WITH GRAVITY-DRIVEN SECONDARY MODE INFUSIONS, SEVERAL FACTORS INFLUENCE THE DURATION OF THE INFUSION INCLUDING: ¿ LARGE SECONDARY CONTAINERS (500 ML OR GREATER). ¿ HIGH SECONDARY RATES (500 ML/H OR GREATER). ¿ USE OF A NON-CAREFUSION SECONDARY SET (WHICH HAS THE POTENTIAL TO CAUSE RESTRICTION AT THE POINT OF CONNECTION TO THE PRIMARY SET PORT). ¿ USE OF CLOSED-SYSTEM DEVICES ABOVE THE PUMP (WHICH CREATES FLOW RESTRICTION IN THE SECONDARY PATH). ¿ UNDER INFUSION CONDITIONS CAN BE THE RESULT OF BACK PRESSURE, WETTED FILTER VENTS (WHEN VENTING IS NEEDED), INCORRECT DISPOSABLE SET INSERTION OR INCORRECT CONTAINER VOLUME ESTIMATION. NONE OF THESE POSSIBLE CAUSES COULD BE INVESTIGATED SINCE IT IS NOT POSSIBLE TO KNOW WHICH IF ANY OF THESE CONDITIONS EXISTED AT THE TIME OF THE CUSTOMER¿S EVENT. ¿ IT SHOULD ALSO BE NOTED THAT VARIATIONS OF HEAD HEIGHT, BACK PRESSURE, OR ANY COMBINATIONS OF THESE MAY AFFECT RATE ACCURACY. FACTORS THAT CAN INFLUENCE HEAD HEIGHT AND BACK PRESSURE ARE ADMINISTRATION SET CONFIGURATION, IV SOLUTION VISCOSITY AND IV SOLUTION TEMPERATURE. ¿ DEVICES WERE IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2).
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.
IT WAS REPORTED THAT THE CUSTOMER IS USING TWO HANGERS TO DROP THE FLUID BAGS AND ARE PROGRAMMING THE VOLUME TO BE INFUSED (VTBI) IN THE PUMP WITH THE OVERFILL AMOUNT INDICATED ON THE EPIC LABEL (AS THEY DID WITH PREVIOUS PUMPS). THERE HAVE BEEN NO CHANGES TO THE WAY THE MEDICATIONS ARE PROGRAMMED IN THE DRUG LIBRARY (SAME AS PREVIOUS PUMPS), AND THE VTBI USED BASED ON THE OVERFILL AMOUNT INDICATED ON THE BAG FROM THE EPIC LABEL, THE SOLUTION BAGS USED, OR THE PRACTICES IN HANGING, BUT THE STAFF ARE REPORTEDLY CONSISTENTLY EXPERIENCING "LEFTOVER AMOUNTS OF MEDICATIONS" THAT ARE IN 500 ML BAGS ALTHOUGH THE (EXACT) LEFTOVER AMOUNT IS INCONSISTENT (25-50 ML). THERE WAS PATIENT INVOLVEMENT, BUT THE IMPACT IS UNKNOWN. ALTHOUGH REQUESTED, FURTHER INFORMATION WAS NOT PROVIDED. BD HAS RECEIVED ADDITIONAL INFORMATION. BD CLINICAL PRACTICE CONSULTANT ENGAGED WITH THE CUSTOMER AND THE FOLLOWING WERE DISCUSSED: UNDER INFUSIONS TEND TO OCCUR WITH 500ML SECONDARY IV CHEMO BAGS. CLINICIANS HAVE HAD THIS ISSUE SINCE ALARIS GO LIVE, THEY DID NOT HAVE THIS ISSUE WITH THEIR PREVIOUS PUMPS. IT WAS DISCUSSED THAT UNDER INFUSIONS CAN BE RELATED TO MULTIPLE FACTORS AND CAN HAVE A COMPOUNDING EFFECT. IT WAS DISCUSSED DIFFERENT AVENUES TO EXPLORE SO THAT WE CAN RULE OUT POTENTIAL CONTRIBUTING FACTORS FOR A ROOT CAUSE ANALYSIS. IT WAS DISCUSSED (USE OF) PRIMARY SHORT SETS AS A POTENTIAL SOLUTION TO REMOVE CHALLENGING SECONDARY DYNAMICS. IT WAS DISCUSSED SENDING AN ENTIRE SET UP - DEVICES, TUBING, ETC. BACK TO BD FOR A FORMAL INVESTIGATION.
IT WAS REPORTED THAT THE CUSTOMER IS USING TWO HANGERS TO DROP THE FLUID BAGS AND ARE PROGRAMMING THE VOLUME TO BE INFUSED (VTBI) IN THE PUMP WITH THE OVERFILL AMOUNT INDICATED ON THE EPIC LABEL (AS THEY DID WITH PREVIOUS PUMPS). THERE HAVE BEEN NO CHANGES TO THE WAY THE MEDICATIONS ARE PROGRAMMED IN THE DRUG LIBRARY (SAME AS PREVIOUS PUMPS), AND THE VTBI USED BASED ON THE OVERFILL AMOUNT INDICATED ON THE BAG FROM THE EPIC LABEL, THE SOLUTION BAGS USED, OR THE PRACTICES IN HANGING, BUT THE STAFF ARE REPORTEDLY CONSISTENTLY EXPERIENCING "LEFTOVER AMOUNTS OF MEDICATIONS" THAT ARE IN 500 ML BAGS ALTHOUGH THE (EXACT) LEFTOVER AMOUNT IS INCONSISTENT (25-50 ML). THERE WAS PATIENT INVOLVEMENT, BUT THE IMPACT IS UNKNOWN. ALTHOUGH REQUESTED, FURTHER INFORMATION WAS NOT PROVIDED. BD HAS RECEIVED ADDITIONAL INFORMATION. BD CLINICAL PRACTICE CONSULTANT ENGAGED WITH THE CUSTOMER AND THE FOLLOWING WERE DISCUSSED: ¿ UNDER INFUSIONS TEND TO OCCUR WITH 500ML SECONDARY IV CHEMO BAGS. CLINICIANS HAVE HAD THIS ISSUE SINCE ALARIS GO LIVE, THEY DID NOT HAVE THIS ISSUE WITH THEIR PREVIOUS PUMPS. ¿ IT WAS DISCUSSED THAT UNDER INFUSIONS CAN BE RELATED TO MULTIPLE FACTORS AND CAN HAVE A COMPOUNDING EFFECT. IT WAS DISCUSSED DIFFERENT AVENUES TO EXPLORE SO THAT WE CAN RULE OUT POTENTIAL CONTRIBUTING FACTORS FOR A ROOT CAUSE ANALYSIS. ¿ IT WAS DISCUSSED (USE OF) PRIMARY SHORT SETS AS A POTENTIAL SOLUTION TO REMOVE CHALLENGING SECONDARY DYNAMICS. ¿ IT WAS DISCUSSED SENDING AN ENTIRE SET UP - DEVICES, TUBING, ETC. BACK TO BD FOR A FORMAL INVESTIGATION. BD REPRESENTATIVES WERE ABLE TO OBSERVE THE REPORTED ISSUE OF UNDER INFUSIONS, WHILE ONSITE. CONTRIBUTING FACTORS INCLUDE LACK OF A PROCESS TO MOVE THE CHEMOTHERAPY TO THE END OF THE IV SET PRIOR TO STARTING THE CHEMOTHERAPY, KINKED IV SETS, AND NOT ENOUGH AIR IN THE IV CHEMOTHERAPY BAG CONTRIBUTING TO A VACUUM, AS EVIDENCED BY OBSERVATIONS OF THE WALLS OF AN IV BAG WARPED / FOLDING IN ON ITSELF, AND A DRIP CHAMBER COLLAPSING. BD REPRESENTATIVES PROVIDED EDUCATION. LINK TO THE BD KNOWLEDGE CENTER WAS PROVIDED TO ACCESS ALARIS TIP SHEETS, VIDEOS, AND RESOURCE MATERIAL.
IT WAS REPORTED THAT THE CUSTOMER IS USING TWO HANGERS TO DROP THE FLUID BAGS AND ARE PROGRAMMING THE VOLUME TO BE INFUSED (VTBI) IN THE PUMP WITH THE OVERFILL AMOUNT INDICATED ON THE EPIC LABEL (AS THEY DID WITH PREVIOUS PUMPS). THERE HAVE BEEN NO CHANGES TO THE WAY THE MEDICATIONS ARE PROGRAMMED IN THE DRUG LIBRARY (SAME AS PREVIOUS PUMPS), AND THE VTBI USED BASED ON THE OVERFILL AMOUNT INDICATED ON THE BAG FROM THE EPIC LABEL, THE SOLUTION BAGS USED, OR THE PRACTICES IN HANGING, BUT THE STAFF ARE REPORTEDLY CONSISTENTLY EXPERIENCING "LEFTOVER AMOUNTS OF MEDICATIONS" THAT ARE IN 500 ML BAGS ALTHOUGH THE (EXACT) LEFTOVER AMOUNT IS INCONSISTENT (25-50 ML). THERE WAS PATIENT INVOLVEMENT, BUT THE IMPACT IS UNKNOWN. ALTHOUGH REQUESTED, FURTHER INFORMATION WAS NOT PROVIDED. BD HAS RECEIVED ADDITIONAL INFORMATION. BD CLINICAL PRACTICE CONSULTANT ENGAGED WITH THE CUSTOMER AND THE FOLLOWING WERE DISCUSSED: UNDER INFUSIONS TEND TO OCCUR WITH 500ML SECONDARY IV CHEMO BAGS. CLINICIANS HAVE HAD THIS ISSUE SINCE ALARIS GO LIVE, THEY DID NOT HAVE THIS ISSUE WITH THEIR PREVIOUS PUMPS. IT WAS DISCUSSED THAT UNDER INFUSIONS CAN BE RELATED TO MULTIPLE FACTORS AND CAN HAVE A COMPOUNDING EFFECT. IT WAS DISCUSSED DIFFERENT AVENUES TO EXPLORE SO THAT WE CAN RULE OUT POTENTIAL CONTRIBUTING FACTORS FOR A ROOT CAUSE ANALYSIS. IT WAS DISCUSSED (USE OF) PRIMARY SHORT SETS AS A POTENTIAL SOLUTION TO REMOVE CHALLENGING SECONDARY DYNAMICS. IT WAS DISCUSSED SENDING AN ENTIRE SET UP - DEVICES, TUBING, ETC. BACK TO BD FOR A FORMAL INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1127273 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015.| 8100. |