FLUSHING PUMP OFP-2 (JP)
Report
- Report Number
- 9611174-2024-01445
- Event Type
- Malfunction
- Date Received
- August 22, 2024
- Date of Event
- August 7, 2024
- Report Date
- October 28, 2024
- 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
- OTHER
- Health Professional
- N
Narratives
E2/E3: NO INFORMATION AVAILABLE FOR THE OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTABLE MALFUNCTION WAS CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: COMPONENT FAILURE OF THE PUMP HEAD. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
IT WAS REPORTED, THAT THE FLUSHING PUMP WAS OCCASIONALLY UNSTABLE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THIS EVENT.
IT WAS REPORTED, THAT THE FLUSHING PUMP WAS OCCASIONALLY UNSTABLE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 941056 | 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 | GIF-H290T. |