MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. FLUSHING PUMP OFP-2 (ROW); OLYMPUS FLUSHING PUMP

Model Number	K10001145
Medical Device Problem Codes	Infusion or Flow Problem (2964); Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failure was confirmed.Based on the results of the investigation a root cause could not be identified.It is likely the following led to the malfunction: component failure of the pump head.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the olympus flushing pump was found to have a flow rate outside the standard range during pre-use inspection.There was no patient involvement.

• Brand Name: FLUSHING PUMP OFP-2 (ROW)
• Common Device Name: OLYMPUS FLUSHING PUMP
• Manufacturer (Section D): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.; keymed house, stock road; southend on sea, essex SS25Q H; UK SS25QH
• Manufacturer (Section G): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.; keymed house, stock road; southend on sea, essex SS25Q H; UK SS25QH
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 24716286
• Report Number: 9611174-2026-00068
• Device Sequence Number: 5763681
• Product Code: FEQ
• UDI-Device Identifier: 15019778003238
• UDI-Public: 15019778003238
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K100899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: K10001145
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown