ALARIS SYSTEM
Report
- Report Number
- 2016493-2023-253141
- Event Type
- Malfunction
- Date Received
- January 8, 2024
- Date of Event
- December 13, 2023
- Report Date
- November 27, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403424267
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 505
Narratives
OMIT : B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE. CORRECTION : DESCRIBE EVENT OR PROBLEM ADDITIONAL INFORMATION : DEVICE EVAL BY MANUFACTURER?, REASON CODE FOR NO EVALUATION, IF OTHER SPECIFY, IMDRF ANNEX A, B, C, D, G CODES 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. H3 OTHER TEXT : NOT APPLICABLE. DEVICE EVALUATED BY BD.
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.
INVESTIGATION SUMMARY: THE REPORT OF AN OVER INFUSION OF A STUDY DRUG ¿HPN 217¿ WAS NOT CONFIRMED THROUGH A REVIEW OF THE LOGS OR REPRODUCED DURING LABORATORY TESTING. REVIEW OF THE LOGS OBSERVED A CALCULATED VOLUME OF 7.095ML DURING THE SUSPECT SYRINGE MODULE¿S LAST INFUSION DATE OF (B)(6) 2023. REVIEW OF THE SYRINGE MODULE EVENT LOG OBSERVED THE USER CHANNELING OFF THE DEVICE 1 MINUTE AND 14 SECONDS BEFORE THE TOTAL PROGRAMMED VOLUME TO BE INFUSED (VTBI) OF 9.14ML WAS COMPLETED. LABORATORY TEST RESULTS PERFORMED ON THE SUSPECT SYRINGE MODULE CONFIRMED THE DEVICE TO BE WITHIN SPECIFICATION AND OPERATING AS INTENDED. THE LOGS IDENTIFIED THAT ON (B)(6) 2023 AT 11:45 AM, A BECTON DICKINSON (BD) 10ML SYRINGE WITH A VOLUME OF 9.4939ML WAS SELECTED. AN INFUSION WITH A RATE OF 20ML/HR, AND A VTBI OF 0.3ML WAS PROGRAMMED AND STARTED (1 MINUTE INFUSION DURATION). AT 11:46 AM, THE INFUSION COMPLETED. THE USER SELECTED THE DEVICE, THEN PROGRAMMED AND STARTED AN INFUSION WITH A RATE OF 99ML/HR, AND A VTBI OF 9.14ML FOR A CALCULATED INFUSION DURATION OF 5 MINUTES AND 32 SECONDS. AT 11:51 AM, THE USER CHANNELED OFF THE UNIT. TOTAL INFUSION DURATION WAS CALCULATED AS 4 MINUTES AND 18 SECONDS. PRIMARY VOLUME INFUSED (PVI) WAS CALCULATED AS 7.095ML. THE UNIT WAS CHANNELED OFF APPROXIMATELY 1 MINUTE AND 14 SECONDS BEFORE THE TOTAL PROGRAMMED VTBI OF 9.14ML WAS COMPLETED. THE REVIEW OF THE SUSPECT SYRINGE MODULE ERROR LOG SHOWED NO ERRORS OR MALFUNCTIONS ON THE OBSERVED INCIDENT DATE FOR THE DEVICE. INTERNAL AND EXTERNAL INSPECTION OF THE SUSPECT SYRINGE MODULE, INCLUDING THE SYRINGE MODULE DRIVE TRAIN, DID NOT IDENTIFY ANY IRREGULARITIES. INSPECTION AND TESTING OF THE INCIDENT BD 10ML SYRINGE AND SYRINGE MODULE ADMINISTRATION SET COULD NOT BE PERFORMED SINCE THEY WERE NOT RETURNED FOR INVESTIGATION. THE ALARIS USER MANUAL HAS INFORMATION FOR THE USER REGARDING PROGRAMMING. THE USER SHOULD CONFIRM CORRECT PROGRAMMING PRIOR TO STARTING THE INFUSION. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF THE REPORT OF AN OVER INFUSION WAS NOT IDENTIFIED DURING THE INVESTIGATION; HOWEVER, A REVIEW OF THE LOGS CONFIRMED THERE WAS A WORKFLOW DEVIATION WHERE THE SUSPECT SYRINGE MODULE WAS CHANNELED OFF BY THE USER 1 MINUTE AND 14 SECONDS BEFORE THE TOTAL PROGRAMMED VTBI OF 9.14ML WAS COMPLETED. NOTE THAT THIS REPORT LISTS IMDRF ANNEX A23, A0509, G0200802, G04070, C23, C07, D02, D11, 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.
IT WAS REPORTED THAT AN INFUSION OF "HPN 217" STUDY DRUG "RAN 3 MINUTES SHORT." THE NURSE NOTED THAT THE VOLUME READ 9.01ML WHEN INSERTED INTO SYRINGE PUMP MODULE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
IT WAS REPORTED THAT AN INFUSION OF "HPN 217" STUDY DRUG RAN 3 MINUTES SHORT. THE NURSE NOTED THAT THE VOLUME READ 9.01ML WHEN INSERTED INTO SYRINGE PUMP MODULE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
IT WAS REPORTED THAT AN INFUSION OF "HPN 217" STUDY DRUG "RAN 3 MINUTES SHORT." THE NURSE NOTED THAT THE VOLUME READ 9.01ML WHEN INSERTED INTO SYRINGE PUMP MODULE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675520 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8110 | 10885403424267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015 |