MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, 0.2 M; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	140149291
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received five new list #140149291 primary plum sets.No damage or anomalies noted.Each set was leak tested per specification.Leakage was observed from the outlet filter of sample 3.The complaint of leaking filter can be confirmed on 1 of 5 samples.The probable cause of the observed leak is due to a pinhole in the filter vent material.The damage is typical of an electrostatic discharge to the filter vent that occurred during manufacturing.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Updated information in d4: model number is not sold in the us, but similar device is sold under model 14001.This product was used for the di and 501k d9 device returned to manufacturer on 6/20/2024.
Additional Manufacturer Narrative
The device is available for evaluation, however, has not yet been received.E1 initial reporter phone number: (b)(6).
Event or Problem Description
The event involved a primary plum set, 15 micron filter in sight chamber, clave secondary port, 0.2 micron filter, polyethylene lined tubing, secure lock, 225 cm where it was reported there was leaking from hospira filter line during infusion.There were no cuts, holes or defects noted on the product.The patient was unable to have remaining few milliliters of systemic anti-cancer treatment (sact).The chemo spill was cleaned up per facility protocol and spill was contained.There was a patient involvement but no patient harm.

• Brand Name: PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, 0.2 M
• 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: 19564109
• Report Number: 9615050-2024-00476
• Device Sequence Number: 17886187
• Product Code: FPA
• UDI-Device Identifier: 00887709100121
• UDI-Public: (01)00887709100121(17)260801(10)13670699
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/16/2024

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 Expiration Date: 08/01/2026
• Device Catalogue Number: 140149291
• Device Lot Number: 13670699
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2023
• 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: SYSTEMIC ANTI-CANCER TREATMENT, UNK MFR.
• Patient Sex: Unknown