ALARIS SYSTEM
Report
- Report Number
- 2016493-2023-219784
- Event Type
- Malfunction
- Date Received
- August 28, 2023
- Date of Event
- April 10, 2023
- Report Date
- September 27, 2023
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Removal / Correction Number
- Z-2718-2020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
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? , REASON CODE FOR NO EVALUATION, IF OTHER SPECIFY, IMDRF ANNEX A,G,B,C,D CODES, REMEDIAL ACTION REQUIRED, REMEDIAL ACTION # 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.
IT WAS REPORTED THAT PRECEDEX, ORDERED TO BE RUNNING AT 0.3MG/HR., WAS SWITCHED OFF. THE CLINICIAN ¿ASSUMED THAT IT WAS SWITCHED OFF BY SOMEONE FOR MAYBE 15-20 MINUTES.¿ THE CLINICIAN REVIEWED THE ¿VERIFY INTAKE AND OUTOUT (I/O)¿ INFORMATION TO SEE WHAT TIME IT WAS SWITCHED OFF, HOWEVER EPIC (ELECTRONIC MEDICAL RECORD) MAR (MEDICATION ADMINISTRATION RECORD) DIDN¿T SHOW THAT INFORMATION. EPIC RECORD SHOWED THAT THE PRECEDEX WAS RUNNING. HOWEVER, THE PUMP WAS OFF. THE CLINICIANS RESTARTED THE INFUSION. CLINICIANS ARE UNSURE WHO SWITCHED OFF THE ALARIS PUMP BETWEEN 12-12:30 OR IF IT TURNED OFF BY ITSELF AND EPIC CONTINUED TO SHOW A CONTINUOUS INFUSION WHILE THE CHANNEL WAS OFF. THERE WAS PATIENT INVOLVEMENT HOWEVER PATIENT HARM IS UNKNOWN. ALTHOUGH REQUEST NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT PRECEDEX, ORDERED TO BE RUNNING AT 0.3MG/HR., WAS SWITCHED OFF. THE CLINICIAN ¿ASSUMED THAT IT WAS SWITCHED OFF BY SOMEONE FOR MAYBE 15-20 MINUTES.¿ THE CLINICIAN REVIEWED THE ¿VERIFY INTAKE AND OUTOUT (I/O)¿ INFORMATION TO SEE WHAT TIME IT WAS SWITCHED OFF, HOWEVER EPIC (ELECTRONIC MEDICAL RECORD) MAR (MEDICATION ADMINISTRATION RECORD) DIDN¿T SHOW THAT INFORMATION. EPIC RECORD SHOWED THAT THE PRECEDEX WAS RUNNING. HOWEVER, THE PUMP WAS OFF. THE CLINICIANS RESTARTED THE INFUSION. CLINICIANS ARE UNSURE WHO SWITCHED OFF THE ALARIS PUMP BETWEEN 12-12:30 OR IF IT TURNED OFF BY ITSELF AND EPIC CONTINUED TO SHOW A CONTINUOUS INFUSION WHILE THE CHANNEL WAS OFF. THERE WAS PATIENT INVOLVEMENT HOWEVER PATIENT HARM IS UNKNOWN. ALTHOUGH REQUEST NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1339963 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | 8015 |