ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-42597
- Event Type
- Malfunction
- Date Received
- November 25, 2024
- Date of Event
- October 29, 2024
- Report Date
- February 4, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CORRECTION: DESCRIBE EVENT OR PROBLEM OMIT: C20 - NO FINDINGS AVAILABLE ADDITIONAL INFORMATION: IMDRF ANNEX A,G,C CODES.
THE ACTUAL DATE OF EVENT IS UNKNOWN. 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. 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: CONCOMITANT MED PROD DATA, D15 - CAUSE NOT ESTABLISHED. CORRECTION: MANUFACTURER NARRATIVE. ADDITIONAL INFORMATION: IMDRF ANNEX D CODES AND MANUFACTURER NARRATIVE. ROOT CAUSE: THE PROBABLE CAUSE OF THE REPORTED OVER INFUSION WAS LIKELY DUE TO HUMAN ERROR. THERE WAS NO SUFFICIENT SAMPLE TO ESCALATE SD DCHU.
ADDITIONAL INFORMATION: IMDRF ANNEX B CODE AND MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. ROOT CAUSE: THE PROBABLE CAUSE OF THE OVER INFUSION WAS NOT IDENTIFIED BY BD TECH SUPPORT DURING THE CUSTOMER CALL. THERE WAS NO SUFFICIENT SAMPLE TO ESCALATE SD DCHU.
IT WAS REPORTED BUMETANIDE 50ML WAS PROGRAMMED AT 12.5 ML/HR, HOWEVER ALLEGEDLY THE INFUSION COMPLETED TOO QUICKLY. CLINICIAN STATED IN "ABOUT 4 HOURS, THE BAG WAS ALREADY EMPTY¿. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED BY PATIENT. ADDITIONAL INFORMATION WAS RECEIVED BY THE CUSTOMER. CUSTOMER REPORTS THAT IT WAS DETERMINED BY THEIR PHARMACY DEPARTMENT TO BE A "HUMAN ERROR.
IT WAS REPORTED BUMETANIDE 50ML WAS PROGRAMMED AT 12.5 ML/HR, HOWEVER ALLEGEDLY THE INFUSION COMPLETED TOO QUICKLY. CLINICIAN STATED IN "ABOUT 4 HOURS, THE BAG WAS ALREADY EMPTY¿. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED BY PATIENT.
IT WAS REPORTED BUMETANIDE 50ML WAS PROGRAMMED AT 12.5 ML/HR, HOWEVER ALLEGEDLY THE INFUSION COMPLETED TOO QUICKLY. CLINICIAN STATED IN "ABOUT 4 HOURS, THE BAG WAS ALREADY EMPTY¿. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED BY PATIENT. ADDITIONAL INFORMATION WAS RECEIVED BY THE CUSTOMER. CUSTOMER REPORTS THAT IT WAS DETERMINED BY THEIR PHARMACY DEPARTMENT TO BE A "HUMAN ERROR.
IT WAS REPORTED BUMETANIDE 50ML WAS PROGRAMMED AT 12.5 ML/HR, HOWEVER ALLEGEDLY THE INFUSION COMPLETED TOO QUICKLY. CLINICIAN STATED IN "ABOUT 4 HOURS, THE BAG WAS ALREADY EMPTY¿. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED BY PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1829707 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015 |