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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. FLUSHING PUMP OFP-2 (EU); OLYMPUS FLUSHING PUMP
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KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. FLUSHING PUMP OFP-2 (EU); OLYMPUS FLUSHING PUMP Back to Search Results
Model Number K10001143
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported the flushing pump had a "bad pump head".There were no reports of patient harm.
 
Manufacturer Narrative
The device is not expected to be returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.
 
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Brand Name
FLUSHING PUMP OFP-2 (EU)
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 Key18848243
MDR Text Key337440975
Report Number9611174-2024-01028
Device Sequence Number1
Product Code FEQ
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberK10001143
Was Device Available for Evaluation? No
Date Manufacturer Received02/07/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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