ALARIS SYSTEM
Report
- Report Number
- 2016493-2022-113144
- Event Type
- Malfunction
- Date Received
- March 10, 2022
- Date of Event
- February 3, 2022
- Report Date
- April 19, 2022
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403811012
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
(B)(6). 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. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.
CORRECTION: OMIT C20 - NO FINDINGS AVAILABLE. ADDITIONAL INFORMATION: MEDICAL DEVICE SERIAL #, DEVICE MANUFACTURE DATE, IMDRF ANNEX A,G,B AND C 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.
IT WAS REPORTED THAT THE MEDICATION WAS SCANNED, THE PUMP WAS ASSOCIATED ON THE COMPUTER BUT DID NOT PULL OVER BACK TO THE PUMP. THE NURSE HAD TO MANUALLY PROGRAM THE HEPARIN DRIP. TWO RN CHECK WAS DONE AND ONCE THE NURSE HIT START ON THE PUMP AND SAVE ON THE COMPUTER, THE PUMP CHANGED THE DOSE A MINUTE LATER. THE INTENDED PROGRAMMING WAS 10 UNIT/KG/HR. BUT THE DOSE THAT ENDED UP RUNNING WAS 28 UNITS/KG/HR. PER HOSPITAL PHARMACIST'S ASSESSMENT BASED ON REVIEWING REPORTS FROM THE CAREFUSION KNOWLEDGE PORTAL (IKP) AND WATCHING THE RN'S CERNER SESSIONS (SMART AUDITOR), THE IKP AND SMART AUDITOR (SA) SHOW MANUAL PROGRAMMING AT 28 UNIT/KG/H. SA SHOWS ATTEMPTED SMART PUMP PROGRAMMING, BUT RN QUICKLY STOPS AND CHOOSES MANUAL PROGRAMMING AND TO MAKE AN ASSOCIATION. 10 UNIT/KG/H WAS BEING SENT TO THE PUMP BEFORE RN STOPPED THE PROGRAMMING. IKP THEN SHOWS MANUAL PROGRAMMING AT 28 UNIT/KG/H. IAWARE (INTEROPERABILITY INTERFACE)SHOWS 10 UNIT/KG/H IN "BLACK" AT 2244, BUT AT 2245 THE DOSE IS 28 UNIT/KG/H IN "PURPLE" (THE SAME TIME IKP RECORDS MANUAL PROGRAMMING OF 28 UNIT/KG/H). THE CUSTOMER WOULD LIKE TO DETERMINE WHAT THE RN ENTERED AT PUMP AT AROUND 2244 ON (B)(6) 2022. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
IT WAS REPORTED THAT THE MEDICATION WAS SCANNED, THE PUMP WAS ASSOCIATED ON THE COMPUTER BUT DID NOT PULL OVER BACK TO THE PUMP. THE NURSE HAD TO MANUALLY PROGRAM THE HEPARIN DRIP. TWO RN CHECK WAS DONE AND ONCE THE NURSE HIT START ON THE PUMP AND SAVE ON THE COMPUTER, THE PUMP CHANGED THE DOSE A MINUTE LATER. THE INTENDED PROGRAMMING WAS 10 UNIT/KG/HR. BUT THE DOSE THAT ENDED UP RUNNING WAS 28 UNITS/KG/HR. PER HOSPITAL PHARMACIST'S ASSESSMENT BASED ON REVIEWING REPORTS FROM THE CAREFUSION KNOWLEDGE PORTAL (IKP) AND WATCHING THE RN'S CERNER SESSIONS (SMART AUDITOR), THE IKP AND SMART AUDITOR (SA) SHOW MANUAL PROGRAMMING AT 28 UNIT/KG/H. SA SHOWS ATTEMPTED SMART PUMP PROGRAMMING, BUT RN QUICKLY STOPS AND CHOOSES MANUAL PROGRAMMING AND TO MAKE AN ASSOCIATION. 10 UNIT/KG/H WAS BEING SENT TO THE PUMP BEFORE RN STOPPED THE PROGRAMMING. IKP THEN SHOWS MANUAL PROGRAMMING AT 28 UNIT/KG/H. IAWARE (INTEROPERABILITY INTERFACE)SHOWS 10 UNIT/KG/H IN "BLACK" AT 2244, BUT AT 2245 THE DOSE IS 28 UNIT/KG/H IN "PURPLE" (THE SAME TIME IKP RECORDS MANUAL PROGRAMMING OF 28 UNIT/KG/H). THE CUSTOMER WOULD LIKE TO DETERMINE WHAT THE RN ENTERED AT PUMP AT AROUND 2244 ON (B)(6)2022. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1574475 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8110 | 10885403811012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 MO | Male |