FDA Adverse Event
Malfunction
Summary report: N
FLUSHING PUMP OFP-2 (JP)
MDR report key: 24119075
·
Received January 20, 2026
Report
- Report Number
- 9611174-2026-00023
- Event Type
- Malfunction
- Date Received
- January 20, 2026
- Report Date
- January 20, 2026
- Manufacturer
- KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
- Product Code
- FEQ
- PMA / PMN Number
- K100899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, FOR THE MALFUNCTION A FLOW RATE GREATER THAN 200 MILLILITERS IN 20 SECOND, THE CAUSE WAS TRACED TO BE COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem · 0
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLUSHING PUMP HAD A FLOW RATE GREATER THAN 200 MILLILITERS IN 20 SECONDS. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177709 | FLUSHING PUMP OFP-2 (JP) | OLYMPUS FLUSHING PUMP | FEQ | KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. | K10001142 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |