ALARIS SYSTEM
Report
- Report Number
- 2016493-2025-122286
- Event Type
- Malfunction
- Date Received
- October 15, 2025
- Date of Event
- September 18, 2025
- Report Date
- November 18, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403519284
- PMA / PMN Number
- K211218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- 505
Narratives
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.
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 ISSUE THAT THE PCU DEVICES HAD ERROR 255-202-2 WAS CONFIRMED AND REPLICATED DURING LABORATORY TESTING. INSPECTION OF THE SUSPECT PCU S/N (B)(6) (MFR REPORT # 2016493-2025-122285) FOUND THE FB9 INDUCTOR DAMAGED. THE INTERNAL INSPECTION OF THE SUSPECT PCU S/N (B)(6) (MFR REPORT # 2016493-2025-122286) FOUND THAT THE REAR CASE BATTERY DISCHARGE RESISTOR HAD MELTED METAL DEPOSITS AROUND THE COMPONENT AND WAS SLIGHTLY MISALIGNED FROM THE DISSIPATOR PLATE. THE EVENT DATE WAS REPORTED AS 18 SEPTEMBER 2025; TIME WAS NOT REPORTED. REVIEW OF THE PCU S/N (B)(6) (MFR REPORT # 2016493-2025-122286) ERROR LOG SHOWED THE ERROR CODE 800.8000 RECORDED ON THE EVENT DATE AT 4:06 PM. THE ERROR CODE 800.8000 INDICATES A SOFTWARE FAULT. EVENT LOG REVIEW REVEALED THE ERROR CODE OCCURRED DURING A FAST BATTERY CONDITIONING TEST. REVIEW OF THE PCU S/N (B)(6) (MFR REPORT # 2016493-2025-122285) ERROR LOG SHOWED THE ERROR CODE 800.8000 RECORDED ON THE 08 SEPTEMBER AT 3:09 PM. THE ERROR CODE 800.8000 INDICATES A SOFTWARE FAULT. EVENT LOG REVIEW REVEALED THE ERROR CODE OCCURRED DURING A FAST BATTERY CONDITIONING TEST. THE SUSPECT DEVICES WERE TESTED PERFORMING THE BATTERY CONDITIONING TEST THROUGH MAINTENANCE MODE. THIS TEST ALLOWS THE PCU SOFTWARE TO DETERMINE THE CAPACITY OF THE BATTERY INSTALLED IN THE DEVICE. THE TEST WAS PERFORMED ON THE ¿AS-RECEIVED¿ DEVICES AND THE ERROR CODE 255-202-2 (800.8000 GENERAL OS FAILURE) WAS REPLICATED. INSPECTION OF THE POWER SUPPLY BOARD OF THE SUSPECT PCU S/N (B)(6) (MFR REPORT # 2016493-2025-122285) FOUND A DAMAGED INDUCTOR (FB9). THE POWER SUPPLY BOARD WAS TEMPORARILY REPLACED WITH A KNOWN GOOD DCHU POWER SUPPLY BOARD FOR TESTING PURPOSES ONLY AND THE BATTERY CONDITIONING TEST WAS PERFORMED AGAIN, THE TEST PASSED SUCCESSFULLY. A POWER SUPPLY BOARD REPLACEMENT WAS CONDUCTED AS WELL FOR THE SUSPECT PCU S/N (B)(6) (MFR REPORT # 2016493-2025-122286), HOWEVER AFTER THE REPLACEMENT OF THE POWER SUPPLY BOARD THE SUSPECT PCU S/N (B)(6) REPLICATED THE SAME ERROR CODE 255- 202-2. IT WAS OBSERVED THAT THE BATTERY DISCHARGE RESISTOR MOUNTING SCREW THREADS WERE DAMAGED. AS SUCH, THE RESISTOR DID NOT MAKE FULL CONTACT WITH THE DISSIPATOR ON THE BACK OF THE REAR CASE AND LED TO THE COMPONENT OVER HEATING AND BEING DAMAGED DURING THE DISCHARGING PHASE OF THE BATTERY CONDITIONING TEST. THE SUSPECT BATTERY DISCHARGE RESISTOR, ALONGSIDE ITS MOUNTING SCREW, WERE TEMPORARILY REPLACED WITH KNOWN-GOOD PARTS FOR TESTING PURPOSES ONLY, AND THE BATTERY CONDITIONING TEST WAS PERFORMED. THE TEST PASSED SUCCESSFULLY. THE BD ALARIS¿ PC UNIT SYSTEM ERROR TIP SHEET NOTES THAT THE BD ALARIS¿ PC UNIT (PCU) SOFTWARE RUNS SELF-CHECKING PROGRAMS PRIOR TO AND DURING OPERATION. A SYSTEM ERROR MESSAGE MEANS THAT THE BD ALARIS¿ SYSTEM HAS IDENTIFIED AN ERROR IN EITHER THE HARDWARE OR THE SOFTWARE OF THE PCU. OBTAIN A NEW PCU. DO NOT POWER DOWN UNTIL A NEW PCU IS AVAILABLE. TAG THE AFFECTED PCU, DESCRIBE THE ERROR AND RETURN IT TO YOUR FACILITY¿S CLINICAL ENGINEERING OR BIOMED DEPARTMENT. ROOT CAUSE: THE ROOT CAUSE OF THE REPORT THAT THE DEVICE HAD ERROR 255-202-2 FOR PCU S/N (B)(6) (MFR REPORT # 2016493-2025-122285) IS BEING ATTRIBUTED TO A DEFECTIVE POWER SUPPLY BOARD. THE ROOT CAUSE OF THE POWER SUPPLY BOARD MALFUNCTION IS ATTRIBUTED TO A DAMAGED INDUCTOR (FB9). THE ROOT CAUSE FOR THE REPORTED ERROR CODE 255-202-2 FOR PCU S/N (B)(6) (MFR REPORT # 2016493-2025-122286) IS BEING ATTRIBUTED TO A DAMAGED REAR CASE BATTERY DISCHARGE RESISTOR. THE ROOT CAUSE FOR THE DAMAGED RESISTOR IS BEING ATTRIBUTED TO DAMAGED THREADS OF THE BATTERY DISCHARGE RESISTOR MOUNTING SCREW. DUE TO THE SCREW THREADS BEING DAMAGED, THE RESISTOR WAS NOT PROPERLY MOUNTED AND DID NOT APPROPRIATELY DISSIPATE HEAT TO THE CHASSIS DURING THE DISCHARGE PHASE OF THE BATTERY CONDITIONING TEST. THIS LED TO THE COMPONENT OVERHEATING, AND THUS GETTING DAMAGED BEFORE THE TEST WAS 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.
IT WAS REPORTED BY CUSTOMER THAT THE PCU HAD AN 800.8000 ERROR CODE. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED BY CUSTOMER THAT THE PCU HAD AN 800.8000 ERROR CODE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2596168 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8015 | 10885403519284 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |