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

Model Number K10001141

Device Problem Difficult to Open or Close (2921)

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

Event Date 02/01/2024

Event Type  malfunction  

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 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.

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 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)
• 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: 18818251
• MDR Text Key: 336735663
• Report Number: 9611174-2024-01020
• Device Sequence Number: 1
• Product Code: FEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K10001141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2014
• 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