MEDFUSION
Report
- Report Number
- 3012307300-2022-03069
- Event Type
- Malfunction
- Date Received
- February 9, 2022
- Report Date
- March 17, 2022
- Manufacturer
- ST PAUL
- Product Code
- FRN
- UDI-DI
- 10610586043567
- PMA / PMN Number
- K111386
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
DEVICE EVALUATION: ONE SMITHS MEDICAL MEDFUSION PUMP WAS RETURNED FOR ANALYSIS WITH A CRACKS ON THE TOP CASE CORNERS, BOTTOM CASE BY L-BRACKET, AND BOTH PLUNGER CASES. EVENT LOG HISTORY WAS PERFORMED AND INDICATED THAT PRIMARY AUDIBLE ALARM WAS RECORDED IN HISTORY. DURING ANALYSIS, THE REPORTED ISSUE WAS UNABLE TO BE DUPLICATED. BASED ON THE EVIDENCE, THE COMPLAINT WAS CONFIRMED, AND THE PROBLEM SOURCE OF THE REPORTED EVENT IS UNKNOWN. SERVICE REPLACED SPEAKER FOR PREVENTIVE.
OTHER, OTHER TEXT: ADDITIONAL EVENT INFORMATION WAS RECEIVED AND B5 WAS UPDATED.
DEVICE EVALUATION: ONE SMITHS MEDICAL MEDFUSION PUMP WAS RETURNED FOR ANALYSIS WITH A CRACKS ON THE TOP CASE CORNERS, BOTTOM CASE BY L-BRACKET, AND BOTH PLUNGER CASES. EVENT LOG HISTORY WAS PERFORMED AND INDICATED THAT PRIMARY AUDIBLE ALARM WAS RECORDED IN HISTORY. DURING ANALYSIS, THE REPORTED ISSUE WAS UNABLE TO BE DUPLICATED. BASED ON THE EVIDENCE, THE COMPLAINT WAS CONFIRMED, AND THE PROBLEM SOURCE OF THE REPORTED EVENT IS UNKNOWN. SERVICE REPLACED SPEAKER FOR PREVENTIVE.
IT WAS REPORTED THAT CONTINUOUS PRIMARY AUDIBLE ALARM WAS EXPERIENCED.
ADDITIONAL INFORMATION RECEIVED AND ATTACHED BY ICU MEDICAL ON 11-FEB-2022:NOT INVOLVED WITH PATIENT.
IT WAS REPORTED THAT CONTINUOUS PRIMARY AUDIBLE ALARM WAS EXPERIENCED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 257722 | MEDFUSION | PUMP, INFUSION | FRN | ST PAUL | 4000-0105-51 | 10610586043567 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |