MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7047-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 9617604-2026-00003-00.The date of that submission was 03-feb-2026.H3: one device was received for evaluation.Visual inspection found no physical damage or other anomalies.Functional testing was performed where the extension set was individually leak tested at 45 psi for 30 sec.Using a hydrostatic pressure pump and no leaks were observed.
Event or Problem Description
It was reported that the pump had been alarming error 45636.The patient had stated that the pump had been leaking and that a wet spot had been noticed on her pants, with the carrying case also wet.The patient had been instructed to open and then close the battery door.A loss of power alarm had been acknowledged.The pump had been powered down, and the clamp on the tubing closest to the picc line had been closed.The pump had been placed in a biohazard bag.The patient had been instructed to call the doctor immediately and had been informed that the infusion could not be stopped for more than four hours.The medication had been blincyto.There were no injury and the event occurred while in use with a patient.

• Brand Name: CADD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25176708
• Report Number: 3012307300-2026-05024
• Device Sequence Number: 16113063
• Product Code: FPA
• UDI-Device Identifier: 10610586020315
• UDI-Public: 10610586020315
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: 21-7047-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown