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

Model Number K10001145

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

The customer reported the flushing pump has intermittent inactivity.The problem occurred during preparation for use/prior to sedation.There were no reports of patient harm.

Event Description

The customer reported the flushing pump has intermittent inactivity.The problem occurred during preparation for use/prior to sedation.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer's final investigation results.The device history record review was performed and found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for inspection, and the reported failure was confirmed.Based on the investigation's results, the malfunction was likely caused by a component failure of the pump head.The cause of the pump head failure could not be determined.The most likely cause is that the performance of a consumable deteriorates as the number of usages increases.Olympus will continue to monitor the field performance of this device.

• Brand Name: FLUSHING PUMP OFP-2 (ROW)
• Type of Device: 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: 18838131
• MDR Text Key: 337320171
• Report Number: 9611174-2024-01025
• Device Sequence Number: 1
• Product Code: FEQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K100899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K10001145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1