MAUDE Adverse Event Report: ICU MEDICAL, INC MEDFUSION 3000 CALIBRATION KIT; PUMP, INFUSION

Catalog Number	3000CAL
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.The device has not been returned to the manufacturer.
Event or Problem Description
It was reported that the calibration appeared to be off on the device.The force dial fdk-20 meter that is part of the 3000cal calibration kit is not working properly and is not accurate in its measurements.The unit is very hard to press and does not zero as it should.Issue has been present since receiving the unit.There was no patient involvement.
Additional Manufacturer Narrative
D4: updated.H3 and h6 codes: updated.No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review with the manufacturing batch review could not be performed.It is not anticipated that the reported malfunction would result in interruption of therapy or serious injury.

• Brand Name: MEDFUSION 3000 CALIBRATION KIT
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23465027
• Report Number: 3012307300-2025-12053
• Device Sequence Number: 8879721
• Product Code: FRN
• UDI-Device Identifier: 10610586031823
• UDI-Public: (01)10610586031823
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K982640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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: Health Professional
• Device Catalogue Number: 3000CAL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 06/29/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown