ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-20999
- Event Type
- Malfunction
- Date Received
- March 25, 2024
- Date of Event
- March 1, 2024
- Report Date
- September 25, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810046
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
CORRECTION: UNIQUE DEVICE IDENTIFIER (UDI)#. ADDED PI TO THE UNIQUE DEVICE IDENTIFIER (UDI)# FIELD. ADDITIONAL INFORMATION: MANUFACTURER NARRATIVE. INVESTIGATION SUMMARY: THE REPORTED COMPLAINT OF A FREE FLOW OF HEPARIN WAS NOT CONFIRMED NOR REPLICATED DURING LABORATORY TESTING. HOWEVER, THE RETURNED PARTIAL IV SET WAS OBSERVED WITH A BROKEN UPPER FITMENT. LABORATORY TESTING CONSISTING OF A ONE-HOUR RATE ACCURACY TEST RESULTS MEASURED THE ACTUAL RATE AT 0.97ML/HR (-3.08% ERROR). THE SPECIFICATION FOR THIS TEST IS +/- 5% INDICATING THE DEVICE WAS WITHIN SPECIFICATION. LABORATORY TESTING OBSERVED NO PERIODS OF UNREGULATED FLOW. THE PUMP MODULE WAS OBSERVED TO PASS ALL TESTING IN ASM. SET LOADING AND UNREGULATED FLOW TESTING DID NOT OBSERVE ANY PERIODS OF UNREGULATED FLOW. SEAR FUNCTIONAL TESTING OBSERVED NO ISSUES. THE PCU AND PUMP MODULE LOGS WERE RETRIEVED FROM THE SYSTEM TO ASCERTAIN EVENT DETAILS ASSOCIATED WITH THE REPORTED EVENT. THE FACILITY REPORTED THE DATE AND TIME OF THE EVENT TO BE 01MAR2024; THE TIME OF THE EVENT WAS NOT REPORTED. A REVIEW OF THE PCU AND PUMP MODULE SYSTEM ERROR LOGS SHOWED NO RECORDS ASSOCIATED WITH THE REPORTED INCIDENT. THE PUMP MODULE S/N (B)(6) WAS POWERED ON (B)(6) 2024 AT 11:49 AM AND CONNECTED AS CHANNEL A. THE PROFILE WAS OBSERVED AS CRITICAL CARE. AT 11:49 AM, THE PUMP MODULE WAS PROGRAMED WITH A PRIMARY INFUSION OF DRUG ID 424 (HEPARIN). RATE= 1ML/HR, VTBI= 400ML PVI= 0ML, SVI= 0ML. AT 11:50 AM, THE INFUSION WAS PAUSED, AND THE PUMP MODULE WAS POWERED OFF. AT 1:56 PM, THE PUMP MODULE S/N (B)(6) WAS PROGRAMMED WITH A PRIMARY INFUSION OF DRUG ID 424 (HEPARIN). RATE= 1ML/HR, VTBI= 400ML, PVI= 0.001ML, SVI= 0ML, AT 1:59 PM, THE INFUSION WAS STOPPED, AND THE PUMP MODULE WAS POWERED OFF. NO FURTHER INFUSIONS WERE OBSERVED ON THE DATE OF THE REPORTED EVENT. THE IV SET WAS OBSERVED WITH STRESS DAMAGE IN THE UPPER FITMENT SECTION. AS A RESULT, TESTING OF THE SET COULD NOT BE PERFORMED. A SEPARATE FILE ((B)(4)) WAS CREATED TO DOCUMENT THE ROOT CAUSE FOR THE DAMAGED SET AND THE SET WAS SENT TO MEDICATION DELIVERY SOLUTIONS FOR A MORE THOROUGH INSPECTION. THE FACILITY WAS CONTACTED TO REQUEST INFORMATION ON IF THEY WERE AWARE THAT THE IV SET WAS BROKEN BEFORE BEING SENT TO BD FOR INSPECTION. THE FACILITY RESPONDED BY STATING THAT THEY WERE NOT AWARE OF THE IV SET BEING BROKEN PRIOR TO SHIPPING, STATING THAT THEY HAD LEFT THE SET INSIDE THE PUMP MODULE WHEN THEY SHIPPED THE DEVICE. ALARIS SYSTEM USER MANUAL (V12.1), STATES WITHIN WARNINGS AND CAUTIONS ¿DO NOT TOUCH THE ADMINISTRATION SET WHILE CLOSING THE DOOR.¿ FAILURE TO FOLLOW THIS INSTRUCTION CAN RESULT IN INFUSION RATE INACCURACY. INSPECTION OF THE SUSPECT PUMP MODULE IUI¿S WERE OBSERVED TO BE IN GOOD CONDITION, THE REAR CASE WAS OBSERVED TO HAVE FLUID CONTAMINATION ON THE INSIDE AND THE ONE-PIECE BEZEL ASSEMBLY WAS OBSERVED TO HAVE A DATE CODE OF OCTOBER 2017 (RECALL NOT AFFECTED) THE PUMP MODULE¿S FRONT DOOR COVER WAS OBSERVED TO BE A THIRD-PARTY PART. A MEDICAL DEVICE SAFETY ALERT WAS SENT OUT ON 7FEB2022 WARNING CUSTOMERS TO ONLY USE BD-APPROVED PARTS WHEN PERFORMING CORRECTIVE MAINTENANCE OR REPAIRS. THE USE OF THIRD-PARTY PARTS CAN AFFECT THE SAFETY AND EFFICACY OF THE BD ALARIS AND ALARIS DEVICES, LEADING TO DEVICE FAILURE, PATIENT INJURY, OR EVEN DEATH. BD RECOMMENDS THE USE OF BD-MANUFACTURED PARTS IN THE SAFE AND EFFECTIVE OPERATION AND MAINTENANCE OF THE ALARIS SYSTEM. THIRD-PARTY PARTS HAVE NOT BEEN VALIDATED BY BD FOR SAFETY AND EFFICACY WITH ALARIS SYSTEM PRODUCTS. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). NOTE: THE PUMPING MECHANISM WAS DISASSEMBLED DURING THE INTERNAL INSPECTION. MECHANISM ASSEMBLIES CANNOT BE REASSEMBLED SINCE MANUFACTURING PERFORMS SEVERAL TESTS NOT AVAILABLE TO DCHU, REPAIR CENTER, OR THE CUSTOMER. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED EVENT OF FREE FLOW OF HEPARIN WAS NOT DEFINITIVELY DETERMINED DURING THE INVESTIGATION. THE RETURNED PUMP MODULE WAS FULLY EVALUATED, AND NO ISSUES OR ANOMALIES WERE OBSERVED DURING THE LOG REVIEW AND LABORATORY TESTING. THE RETURNED IV SET WAS RECEIVED WITH THE UPPER HALF OF THE COMPONENTS BROKEN; HOWEVER, IT MAY HAVE BEEN DAMAGED DURING TRANSPORT AS THE FACILITY STATED THE SET WAS INSIDE THE DEVICE WHEN SHIPPED. NOTE THAT THIS REPORT LISTS IMDRF ANNEX A1801, G04037, C0601 AND D15 CODES NOT ASSOCIATED WITH THE REPORTED EVENT 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 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. 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 HEPARIN HAD BEEN PRIMED EARLIER IN THE DAY AND WAS SET UP ON THE PUMP MODULE AWAITING A POST-OP PATIENT TO ARRIVE IN THE CARDIAC INTENSIVE CARE UNIT (CVICU). THE PUMP MODULE DOOR WAS CLOSED. THE NURSE TURNED THE PCU BACK ON AND RESTORED THE HEPARIN PROGRAMMING ON THE PUMP MODULE TO 1ML/HOUR, AT THIS TIME THE TUBING WAS NOT HOOKED UP TO THE PATIENT. THE NURSE WENT TO GRAB THE TUBING TO HOOK IT UP TO THE PATIENT AND EXPECTED TO SEE A FEW DROPS OF FLUID, INSTEAD SAW A "STEADY STREAM OF FLUID RUSHING OUT OF THE TUBING AND THERE WAS A LARGE PUDDLE ON THE FLOOR." PER BIOMED, THE TUBING WAS THEN SETUP IN A DIFFERENT PUMP MODULE "AND SEEMED TO BE WORKING NORMALLY." PER REPORT, PATIENT WAS NOT IMPACTED AS THE EVENT OCCURRED PRIOR TO CONNECTING THE TUBING TO THE PATIENT.
IT WAS REPORTED THAT HEPARIN HAD BEEN PRIMED EARLIER IN THE DAY AND WAS SET UP ON THE PUMP MODULE AWAITING A POST-OP PATIENT TO ARRIVE IN THE CARDIAC INTENSIVE CARE UNIT (CVICU). THE PUMP MODULE DOOR WAS CLOSED. THE NURSE TURNED THE PCU BACK ON AND RESTORED THE HEPARIN PROGRAMMING ON THE PUMP MODULE TO 1ML/HOUR, AT THIS TIME THE TUBING WAS NOT HOOKED UP TO THE PATIENT. THE NURSE WENT TO GRAB THE TUBING TO HOOK IT UP TO THE PATIENT AND EXPECTED TO SEE A FEW DROPS OF FLUID, INSTEAD SAW A "STEADY STREAM OF FLUID RUSHING OUT OF THE TUBING AND THERE WAS A LARGE PUDDLE ON THE FLOOR." PER BIOMED, THE TUBING WAS THEN SETUP IN A DIFFERENT PUMP MODULE "AND SEEMED TO BE WORKING NORMALLY." PER REPORT, PATIENT WAS NOT IMPACTED AS THE EVENT OCCURRED PRIOR TO CONNECTING THE TUBING TO THE PATIENT.
IT WAS REPORTED THAT HEPARIN HAD BEEN PRIMED EARLIER IN THE DAY AND WAS SET UP ON THE PUMP MODULE AWAITING A POST-OP PATIENT TO ARRIVE IN THE CARDIAC INTENSIVE CARE UNIT (CVICU). THE PUMP MODULE DOOR WAS CLOSED. THE NURSE TURNED THE PCU BACK ON AND RESTORED THE HEPARIN PROGRAMMING ON THE PUMP MODULE TO 1ML/HOUR, AT THIS TIME THE TUBING WAS NOT HOOKED UP TO THE PATIENT. THE NURSE WENT TO GRAB THE TUBING TO HOOK IT UP TO THE PATIENT AND EXPECTED TO SEE A FEW DROPS OF FLUID, INSTEAD SAW A "STEADY STREAM OF FLUID RUSHING OUT OF THE TUBING AND THERE WAS A LARGE PUDDLE ON THE FLOOR." PER BIOMED, THE TUBING WAS THEN SETUP IN A DIFFERENT PUMP MODULE "AND SEEMED TO BE WORKING NORMALLY." PER REPORT, PATIENT WAS NOT IMPACTED AS THE EVENT OCCURRED PRIOR TO CONNECTING THE TUBING TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 436017 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015.| 8100. |