MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 2 CLAVE MULTIPORT CONNECTOR, BALL CHECK VALVE IN SIGHT CHAMBER; SET, ADMINISTATION, INTRAVASCULAR

Catalog Number	121939290
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation, as contained cytotoxics, however a lot of history reviewed will be performed.
Event or Problem Description
The event involved a primary plum set, 2 clave multiport connector, ball check valve in sight chamber where the customer reported that when connecting the extension tube (which came prepared from the pharmacy) to one of the access claves for administering cytostatics, it was not possible to pass the medicine through.The clave was obstructed internally and did not allow the medicine to pass through (the connections are clave spirals and were perfectly hooked).The nurses changed the access from the extension rod to another key on the same device and were able to pass the medication through without any problems.The conclusion was that the keys were damaged internally and would not allow the liquid to pass through.The problem was identified when programming the pump, with the device connected by the clave to the spirals and the plum pump emitting a distal occlusion beep.This happened with 3 devices.The event occurred during patient use, there was no one harmed as a result of this event.
Additional Manufacturer Narrative
A picture was returned showing a blue arrow pointing to the blue clave of a primary plum set the complaint of occlusion could not be confirmed based on the returned image.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, 2 CLAVE MULTIPORT CONNECTOR, BALL CHECK VALVE IN SIGHT CHAMBER
• Common Device Name: SET, ADMINISTATION, 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: 20372672
• Report Number: 9615050-2024-00734
• Device Sequence Number: 6859851
• Product Code: FPA
• UDI-Device Identifier: 00887709100121
• UDI-Public: (01)00887709100121(17)261101(10)13809673
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: 121939290
• Device Lot Number: 13809673
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CYTOSTATICS, MFR UNK.; PLUM PUMP, ICU MEDICAL.
• Patient Sex: Unknown