ALARIS SYSTEM
Report
- Report Number
- 2016493-2025-61722
- Event Type
- Malfunction
- Date Received
- February 10, 2025
- Date of Event
- January 14, 2025
- Report Date
- November 3, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- MEA
- UDI-DI
- 10885403516030
- PMA / PMN Number
- K211218
- Removal / Correction Number
- Z-0186-2024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
OMIT : B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE. ADDITIONAL INFORMATION: DEVICE EVAL BY MANUFACTURER?, IMDRF ANNEX A, B, C, D, G CODES AND 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 EVENT OF THE SYRINGE NOT RECOGNIZED WAS CONFIRMED. ¿ LABORATORY TESTS WERE ABLE TO REPLICATE THE REPORTED EVENT OF NOT RECOGNIZING A BD 30ML SYRINGE. ¿ A CALIBRATION TEST WAS PERFORMED FOR BOTH PCA MODULES THROUGH ALARIS¿ SYSTEM MAINTENANCE (ASM) SO THAT THE SYRINGES COULD BE PROPERLY DETECTED ON THE DEVICE. ¿ BOTH SUSPECT PCA MODULES PASSED ALL PM (PREVENTIVE MAINTENANCE) TESTS, POST CALIBRATION IN ALARIS SYSTEM MAINTENANCE (ASM) (V12.5). ¿ SYRINGE RECOGNITION TESTS WERE PERFORMED ON BOTH SUSPECTED PCA MODULES POST CALIBRATION TO SEE IF THE ISSUE OF SYRINGE DETECTION FAILURE MENTIONED BY THE FACILITY NO LONGER PERSISTED, RESULTING IN THE RECOGNITION OF THE INSTALLED SYRINGES. ¿ THERE WAS NO PATIENT INVOLVED; THEREFORE, A REVIEW OF DEVICE LOGS IS NOT NECESSARY. ¿ MODEL 8120 (PCA MODULE) S/N (B)(6) SUSPECT. ¿ AN INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED FOR THE SUSPECT PCA MODULE, AND NO ISSUES WERE FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED. ¿ MODEL 8120 (PCA MODULE) S/N (B)(6) SUSPECT. ¿ AN INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED FOR THE SUSPECT PCA MODULE, AND NO ISSUES WERE FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED. ¿ THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). NOTE TO REPAIR CENTER: DEVICE WAS DISASSEMBLED FOR THIS INVESTIGATION, PLEASE ENSURE PROPER ASSEMBLY, TORQUING OF SCREWS, AND APPROPRIATE TESTING IS PERFORMED. REPAIR CENTER SHOULD FOLLOW THEIR NORMAL PROCESSING OF THE DEVICE, LOOKING FOR ANY INCIDENTAL ISSUES PRIOR TO RETURNING IT TO THE CUSTOMER. DCHU WILL NOT BE PICKING UP THE COST OF THE INCIDENTAL REPAIRS. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED ISSUE OF SYRINGE NOT RECOGNIZED COULD NOT BE DEFINITIVELY DETERMINED, HOWEVER, DEVICE TESTING REPLICATED A SIMILAR EVENT OF NOT RECOGNIZING THE BD 30 ML SYRINGE WITH THE ISSUE CORRECTED WITH RECALIBRATION OF THE PCA MODULE.
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED. 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: REMEDIAL ACTION REQUIRED, REMEDIAL ACTION #.
OMIT: A170101 - ACCESSORY INCOMPATIBLE (1004), G04127 - SYRINGE, C05 - LABELING AND INSTRUCTIONS FOR USE/MAINTENANCE, D0106 - DESIGN CHANGE VALIDATION INADEQUATE, REMEDIAL ACTION REQUIRED, REMEDIAL ACTION #. ADDITIONAL INFORMATION: DEVICE EVAL BY MANUFACTURER?, IMDRF ANNEX A, C, D, G CODES AND MANUFACTURER NARRATIVE. 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 BY THE CLINICIAN THAT DURING EDUCATION, TWO PCA MODULES DISPLAYED THE ERROR MESSAGE THAT THEY WERE UNABLE TO RECOGNIZE THE LOADED SYRINGE. THE BD 30ML SYRINGE WAS LOADED CORRECTLY INTO BOTH DEVICES AND THE ISSUE IS INTERMITTENT. THE DEVICES WILL RECOGNIZE THE SYRINGE THEN IT WOULD BE UNABLE TO RECOGNIZE THE SYRINGE. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED BY THE CLINICIAN THAT DURING EDUCATION, TWO PCA MODULES DISPLAYED THE ERROR MESSAGE THAT THEY WERE UNABLE TO RECOGNIZE THE LOADED SYRINGE. THE BD 30ML SYRINGE WAS LOADED CORRECTLY INTO BOTH DEVICES AND THE ISSUE IS INTERMITTENT. THE DEVICES WILL RECOGNIZE THE SYRINGE THEN IT WOULD BE UNABLE TO RECOGNIZE THE SYRINGE. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED BY THE CLINICIAN THAT DURING EDUCATION, TWO PCA MODULES DISPLAYED THE ERROR MESSAGE THAT THEY WERE UNABLE TO RECOGNIZE THE LOADED SYRINGE. THE BD 30ML SYRINGE WAS LOADED CORRECTLY INTO BOTH DEVICES AND THE ISSUE IS INTERMITTENT. THE DEVICES WILL RECOGNIZE THE SYRINGE THEN IT WOULD BE UNABLE TO RECOGNIZE THE SYRINGE. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED BY THE CLINICIAN THAT DURING EDUCATION, TWO PCA MODULES DISPLAYED THE ERROR MESSAGE THAT THEY WERE UNABLE TO RECOGNIZE THE LOADED SYRINGE. THE BD 30ML SYRINGE WAS LOADED CORRECTLY INTO BOTH DEVICES AND THE ISSUE IS INTERMITTENT. THE DEVICES WILL RECOGNIZE THE SYRINGE THEN IT WOULD BE UNABLE TO RECOGNIZE THE SYRINGE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 872184 | ALARIS SYSTEM | PUMP, INFUSION | MEA | CAREFUSION SD | 8120 | 10885403516030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015 |