ALARIS SYSTEM
Report
- Report Number
- 2016493-2022-173989
- Event Type
- Injury
- Date Received
- August 8, 2022
- Date of Event
- July 1, 2022
- Report Date
- December 2, 2022
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. 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.
OMIT: B17 - DEVICE NOT RETURNED, B15 - ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE RETURN TO MANUF .?, DEVICE EVAL BY MANUFACTURER?, IF OTHER SPECIFY, IMDRF ANNEX A, G, B, C AND D CODES. H3 OTHER TEXT: NOT APPLICABLE. DEVICE EVALUATED BY BD.
CORRECTION TO REMOVE : E2401 - INSUFFICIENT INFORMATION, F24 - INSUFFICIENT INFORMATION, C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. CORRECTION : DATE OF EVENT, DESCRIBE EVENT OR PROBLEM, CONCOMITANT MED PROD DATA, TYPE OF REPORTABLE EVENTS. ADDITIONAL INFORMATION : AGE AT TIME OF EVENT, AGE UNIT, DATE OF BIRTH, SEX, WEIGHT, WEIGHT UNIT, ADVERSE TYPE, EVENT ATTRIBUTED TO, OTHER RELEVANT HISTORY, IMDRF ANNEX A, B, C, D, E, F, 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.
IT WAS REPORTED THAT THE PUMP SCREEN SHUT OFF DURING INFUSION. THE CUSTOMER ADDITIONALLY INDICATED "POTENTIAL OVER-INFUSION" ALTHOUGH REQUESTED, NO ADDITIONAL DETAILS WERE PROVIDED.
IT WAS REPORTED THAT THE PCU AND PUMP MODULE DISPLAY SHUT OFF DURING INFUSION. THE PUMP WAS SET UP WITH TWO MODULES CONNECTED. CHANNEL A WAS INFUSING PRECEDEX AND CHANNEL B WAS INFUSING PROPOFOL. BOTH MEDICATIONS WERE CONNECTED TO THE PATIENT'S CENTRAL LINE VIA A MANIFOLD ALONG WITH ADDITIONAL UNSPECIFIED MEDICATION LINES BEING INFUSED FROM A DIFFERENT PUMP. AT 1600, THE PROPOFOL INFUSION WAS STOPPED. AT 1800, THE PRECEDEX INFUSION WAS STOPPED AND THE DEVICE TURNED POWERED OFF. A FEW MINUTES LATER, THE CLINICIAN NOTED THAT THE PATIENT'S MEAN ARTERIAL PRESSURE (MAP) WAS DECREASING. THE CLINICIAN ADMINISTERED ADDITIONAL NOREPINEPHRINE TO MAINTAIN MAP ABOVE 65MMHG. AT THIS TIME, THE CLINICIAN NOTED THAT MEDICATION WAS CONTINUING TO FLOW FROM THE POWERED DOWN PUMP AND MANUALLY CLAMPED THE TUBING.
IT WAS REPORTED THAT THE PCU AND PUMP MODULE DISPLAY SHUT OFF DURING INFUSION. THE PUMP WAS SET UP WITH TWO MODULES CONNECTED. CHANNEL A WAS INFUSING PRECEDEX AND CHANNEL B WAS INFUSING PROPOFOL. BOTH MEDICATIONS WERE CONNECTED TO THE PATIENT'S CENTRAL LINE VIA A MANIFOLD ALONG WITH ADDITIONAL UNSPECIFIED MEDICATION LINES BEING INFUSED FROM A DIFFERENT PUMP. AT 1600, THE PROPOFOL INFUSION WAS STOPPED. AT 1800, THE PRECEDEX INFUSION WAS STOPPED AND THE DEVICE TURNED POWERED OFF. A FEW MINUTES LATER, THE CLINICIAN NOTED THAT THE PATIENT'S MEAN ARTERIAL PRESSURE (MAP) WAS DECREASING. THE CLINICIAN ADMINISTERED ADDITIONAL NOREPINEPHRINE TO MAINTAIN MAP ABOVE 65MMHG. AT THIS TIME, THE CLINICIAN NOTED THAT MEDICATION WAS CONTINUING TO FLOW FROM THE POWERED DOWN PUMP AND MANUALLY CLAMPED THE TUBING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2245377 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Required Intervention | 8015| 8100 (3)| 8100 (3) |