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

Model Number	K10001141
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
It was reported that the pump head does not close over the tubing.It was also reported that the pump head had never been replaced and was in bad shape.The procedure to be performed was diagnostic in nature and was completed using the same equipment.There were no reports of patient harm.
Additional Manufacturer Narrative
Updated fields: g3, h2, h4, h6, h10 this report is being supplemented to provide additional information based on the approved final investigation.The device was not returned to olympus for evaluation, as customer advised the device will be retained.The customer was advised the pump head be replaced annually.The most probable cause of the complaint is traced to component failure, which is expected or random component failure without any design or manufacturing issue.The customer was provided replacement part information and educated on device replacement guidelines.A device history review of the current product was conducted, and no problems were found.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported that the pump head does not close over the tubing.It was also reported that the pump head had never been replaced and was in bad shape.The procedure to be performed was diagnostic in nature and was completed using the same equipment.There were no reports of patient harm.

• Brand Name: FLUSHING PUMP OFP-2 (US)
• 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: 18818251
• Report Number: 9611174-2024-01020
• Device Sequence Number: 15549353
• Product Code: FEQ
• UDI-Device Identifier: 15019778003191
• UDI-Public: 15019778003191
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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: K10001141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown