MAUDE Adverse Event Report: MOOG MEDICAL DEVICES CURLIN 6000 CMS IV INFUSION PUMP

Model Number	360-1400P
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to mmd for investigation.A dhr review was not completed because the device serial number was not provided.Because the device was not returned to mmd, no investigation could be performed.This report will be updated if the device is returned to mmd.
Event or Problem Description
The initial reporter stated that the pump was over infused.They stated that the pump was supposed to infuse for twelve hours, but that it completed the infusion in six hours.Mmd did follow up with the initial reporter, who stated that the patient had not experienced any adverse effects due to the complaint.No other information was provided.(b)(4).

• Brand Name: CURLIN 6000 CMS IV INFUSION PUMP
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): MOOG MEDICAL DEVICES; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer Contact: kristin egelhoff ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 24875048
• Report Number: 1722139-2026-00115
• Device Sequence Number: 13231107
• Product Code: FRN
• UDI-Device Identifier: 10814844000365
• UDI-Public: 10814844000365
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K981816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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: Other
• Device Model Number: 360-1400P
• Device Catalogue Number: 360-1400P
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 69 YR
• Patient Sex: Unknown