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

Catalog Number	21-7308-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when compounding blinatumomab in cassette reservoir, the outer plastic cover was clicked into place like normal, and when the nurses went to hook it up to the patient, they have noticed that the cadd (ambulatory infusion device cassette) was swimming in drug, and a split had occurred.There was no patient involvement, and no patient harm / adverse event reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
D4 - expiration date and d4 - primary udi number: correction h3 and h6.Codes: updated.Device evaluation: a picture was returned showing a cassette and an extension set inside a bag with fluid droplets.The source of the fluid is unclear.Received one (1) used reservoir, cassette.As received no damage or anomalies were observed.To replicate clinical use the cassette was filled with 250 ml of water using an icu medical provided syringe.No leakage was observed.The complaint of leakage could not be replicated or confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: CADD MEDICATION CASSETTE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; industrial internacional; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24649776
• Report Number: 3012307300-2026-02756
• Device Sequence Number: 9760729
• Product Code: FPA
• UDI-Device Identifier: 10610586032370
• UDI-Public: (01)10610586032370(17)300709(10)6132903
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: 21-7308-24
• Device Lot Number: 6132903
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/12/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLINATUMOMAB, UNK MFR
• Patient Sex: Unknown