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

Model Number	360-1400P
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to mmd for evaluation.A dhr review was completed and no non-conformances were found.When the device was returned to mmd for investigation, the was severe fluid ingress damaging several components of the pump, including the pcb board and causing the auxiliary alarm to fail.The pump was scheduled to be scrapped due to the extent of the damage.
Event or Problem Description
The initial reporter stated that the pump auxiliary alarm did not operate as expected.They stated that it failed to alarm.They stated that the pump would shut down if it was unplugged from ac power.Mmd did follow up with the initial reporter, who advised that no patient had been involved and that the complaint had occurred during testing.No additional information was provided.(b)(4).

• Brand Name: CURLIN 6000 CMS 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 ; 8002641001
• MDR Report Key: 25019234
• Report Number: 1722139-2026-00129
• Device Sequence Number: 13345422
• Product Code: FRN
• UDI-Device Identifier: 10814844000365
• UDI-Public: 10814844000365
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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 Sex: Unknown