FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3083779
·
Received April 29, 2013
Report
- Report Number
- 1416980-2013-10750
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Date of Event
- April 12, 2013
- Report Date
- April 12, 2013
- Manufacturer
- SHARP CORPORATION OSAKA JAPAN
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF AN OCCLUSION ALARM WAS CONFIRMED DURING DEVICE EVALUATION ONSITE BY A FIELD SERVICE TECHNICIAN. THE LATCH ROLLER WAS FOUND TO BE DAMAGED AS A RESULT OF NORMAL WEAR AND TEAR. THE LATCH ROLLER WAS REPLACED TO CORRECT THE REPORTED CONDITION.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP THAT ALARMED AN OCCLUSION. IT IS UNKNOWN IN WHICH CARE AREA OR THE PROCESS STEP THAT THIS EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185470 | FLOGARD | PUMP, INFUSION | FRN | SHARP CORPORATION OSAKA JAPAN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |