ALARIS SYSTEM
Report
- Report Number
- 2016493-2025-110984
- Event Type
- Malfunction
- Date Received
- September 4, 2025
- Date of Event
- August 12, 2025
- Report Date
- December 8, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810046
- PMA / PMN Number
- K211218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
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.
CORRECTION: IT WAS DETERMINED THROUGH INVESTIGATION OF THE RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER: 2016493-2025-110984 IS A CONCOMITANT. THE DEVICE WAS AFFECTED DUE TO THE ISSUE OBSERVED ON THE SUSPECT DEVICE CAPTURED IN MANUFACTURER REPORT NUMBER: 2016493-2025-111743.
IT WAS REPORTED THAT THERE WAS AN UNDER INFUSION OF CEFTAROLINE (CEFTAROLINE 5.92 MG IN NSS 0.5 ML IVPB). THE ELECTRONIC MEDICAL RECORD (EMR) RECORDED ADMINISTRATION OF CEFTAROLINE, HOWEVER THE PATIENT DID NOT ACTUALLY RECEIVE THE MEDICATION. THE RATE, DATE/TIME SEEN IN THE EMR UNDER CEFTAROLINE IS THE RATE, DATE/TIME FOR THE INFUSION OF BLOOD (TRANSFUSE RBC) 14 ML. THE EVENT OCCURRED BETWEEN 0500-0800. THE RATES RECORDED IN THE EMR FOR CEFTAROLINE WAS ACTUALLY THE RATE OF THE BLOOD ACCORDING TO THE NURSE. 0528 ¿ 5 ML/HOUR, 0530 3.73 ML/HOUR, 0532 ¿ 4.91 ML/HOUR, 0600 ¿ 4.91 ML/HOUR, 0800 ¿ 4.91 ML/HOUR, 0821 ¿ NEW BAG, 0823 ¿ 1.5 ML/HOUR. THE BLOOD INFUSION WAS PROGRAMMED MANUALLY, THEY DID SCAN CEFTRAOLINE BUT IT IS NOT BUILT IN THE NEONATAL DRUG LIBRARY. CEFTRAOLINE DID ASSOCIATE TO THE PUMP FROM NIGHT¿S DOSE THE DAY PRIOR TO THE EVENT. THERE WAS NO PATIENT HARM.
IT WAS REPORTED THAT THERE WAS AN UNDER INFUSION OF CEFTAROLINE (CEFTAROLINE 5.92 MG IN NSS 0.5 ML IVPB). THE ELECTRONIC MEDICAL RECORD (EMR) RECORDED ADMINISTRATION OF CEFTAROLINE, HOWEVER THE PATIENT DID NOT ACTUALLY RECEIVE THE MEDICATION. THE RATE, DATE/TIME SEEN IN THE EMR UNDER CEFTAROLINE IS THE RATE, DATE/TIME FOR THE INFUSION OF BLOOD (TRANSFUSE RBC) 14 ML. THE EVENT OCCURRED BETWEEN 0500-0800. THE RATES RECORDED IN THE EMR FOR CEFTAROLINE WAS ACTUALLY THE RATE OF THE BLOOD ACCORDING TO THE NURSE. 0528 ¿ 5 ML/HOUR, 0530 3.73 ML/HOUR, 0532 ¿ 4.91 ML/HOUR, 0600 ¿ 4.91 ML/HOUR, 0800 ¿ 4.91 ML/HOUR, 0821 ¿ NEW BAG, 0823 ¿ 1.5 ML/HOUR. THE BLOOD INFUSION WAS PROGRAMMED MANUALLY, THEY DID SCAN CEFTRAOLINE BUT IT IS NOT BUILT IN THE NEONATAL DRUG LIBRARY. CEFTRAOLINE DID ASSOCIATE TO THE PUMP FROM NIGHT¿S DOSE THE DAY PRIOR TO THE EVENT. THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1386229 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |