FDA Adverse Event
Malfunction
Summary report: N
MEDFUSION
MDR report key: 11182889
·
Received January 16, 2021
Report
- Report Number
- 3012307300-2021-00517
- Event Type
- Malfunction
- Date Received
- January 16, 2021
- Report Date
- January 17, 2021
- Manufacturer
- ST PAUL
- Product Code
- FRN
- UDI-DI
- 10610586032318
- PMA / PMN Number
- K040899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
RETURNED DEVICE WAS RECEIVED PUMP EXTERIOR VERY DIRTY. BOTTOM CASE BADLY CRACKED BY L-BRACKET. EVIDENCE OF REPORTED PROBLEM IN EVENT LOG WAS FOUND. DURING THE EVALUATION OF THE DEVICE THE CUSTOMER REPORTED CONDITION WAS CONFIRMED. PROBLEM SOURCE IS UNKNOWN. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SMITHS MEDICAL PUMP HAD A POSITIVE SUPPLY BACKGROUND TEST FAILURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 79044 | MEDFUSION | PUMP, INFUSION | FRN | ST PAUL | 3500-500 | 10610586032318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |