MEDFUSION
Report
- Report Number
- 3012307300-2022-03071
- Event Type
- Malfunction
- Date Received
- February 9, 2022
- Report Date
- November 14, 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 AND BOTTOM CASE BY L-BRACKET. 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.
DEVICE EVALUATION: ONE SMITHS MEDICAL MEDFUSION PUMP WAS RETURNED FOR ANALYSIS WITH A CRACKS ON THE TOP CASE CORNERS AND BOTTOM CASE BY L-BRACKET. 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 TEXT: B5: ADDITIONAL INFORMATION RECEIVED ON 09-NOV-2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: FOR POST PAA-PRIMARY CONTINUOUS ALARMING. NO INCIDENT WAS REPORTED ON THE CLINICAL SIDE. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. THE CUSTOMER REPORTED PROBLEM WAS NOT RELATED TO ANY PREVIOUS REPAIR. VISUAL INSPECTION FOUND THE DEVICE WITH THE TAMPER SEALS BROKEN. TOP CASE CORNERS CRACKED, AND BOTTOM CASE CRACKED BY L-BRACKET. THERE WAS EVIDENCE OF THE ERROR RECORDED IN THE EVENT HISTORY LOG. THE REPORTED PROBLEM WAS NOT DUPLICATED. THE INVESTIGATION WAS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED PROBLEM AS NO DAMAGE WAS FOUND WITH THE SPEAKER. IT WAS RECOMMENDED TO HAVE THE SPEAKER REPLACED AS A PREVENTATIVE MEASURE. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS UNDETERMINED/UNKNOWN. A MANUFACTURING DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE. NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMERS REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. THE DEVICE IS OVER THREE YEARS OLD. AN INTERNAL CAPA HAS BEEN OPENED AND THIS ISSUE WILL BE MONITORED FOR ANY INCREASE IN OCCURRENCE. IF THE OCCURRENCE OF THIS ISSUE INCREASES SIGNIFICANTLY, ADDITIONAL CORRECTIVE ACTIONS WILL BE TAKEN., CORRECTED DATA: CORRECTION: D4: MODEL NUMBER: 4000.
IT WAS REPORTED THAT A CONTINUOUS PRIMARY AUDIBLE ALARM WAS EXPERIENCED.
IT WAS REPORTED THAT A CONTINUOUS PRIMARY AUDIBLE ALARM WAS EXPERIENCED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 326631 | MEDFUSION | PUMP, INFUSION | FRN | ST PAUL | 4000 | 10610586043567 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |