MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 4 CLAVE MULTIPORT CONNECTOR, BALL CHECK VALVE IN SIGHT CHAMBER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	121959290
Medical Device Problem Codes	Fluid/Blood Leak (1250); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone is: (b)(6).The device has been discarded.The investigation is pending completion.
Event or Problem Description
It was reported that a primary plum set, 4 clave multiport connector, ball check valve in sight chamber, 15 micron filter, clave secondary port, clave y-site, polyethylene lined light resistant tubing, secure lock, 216 cm had a leak issue.It was stated that ¿infusion was set up correctly from one of the connection ports, but the drug being infused was coming out of another port that was not in use.The problem was only highlighted on one device of the indicated batch.¿ sample picture was not provided.Drug used: ciclofosfamide.The leak occurred few minutes after the infusion started.The pump was set at 125 ml/h.The pump did not alarm.The plum set has been removed and discarded according to the procedure.No blood loss considered clinically significant.The set was replaced, therapy resumed, the infusion continued.A retracted valve was detected.The leak did not come into contact with the patient or healthcare professional.The leak was managed as per internal procedure ( spill kit used).The device involved was discarded.The event occurred during patient use, no adverse event, no human harm, no need for medical intervention.There was a delay in therapy.
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint of stick down and subsequent leakage can be confirmed based on lot history.The probable cause is due to a manufacturing assembly.The lot history was reviewed and the following nonconformity was identified: exception type: ncmr, document id: (b)(4).Lot#: 13527107, discrepancy: "during heighten inspection for quality alert qa found 2 subassemblies with stick-down in bag #49.Qty: (b)(4).Per(b)(4): activation test activate clave.Reject if silicone does not immediately return to unactivated position.Fixture(s): t-4256.Maintenance work order number: bracketing to follow.".

• Brand Name: PRIMARY PLUM SET, 4 CLAVE MULTIPORT CONNECTOR, BALL CHECK VALVE IN SIGHT CHAMBER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21082918
• Report Number: 9615050-2025-00010
• Device Sequence Number: 12470515
• Product Code: FPA
• UDI-Device Identifier: 00887709102460
• UDI-Public: (01)00887709102460(17)260901(10)13702807
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K141789
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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 Expiration Date: 09/01/2026
• Device Catalogue Number: 121959290
• Device Lot Number: 13702807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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
• Patient Sex: Unknown