MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142540489
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a primary plum set, clave secondary port, 2 clave y-sites, 0.2 micron filter, secure lock, 112 inch.As per report, patient noticed during durvalumab infusion that her arm was wet.Upon further inspection, a small hole on the back of the filter at the most distal end was spurting fluid.This was not a crack, as the hole is part of every filter, however, it should not have been leaking.Infusion paused and skin dried and cleaned.Team lead was notified.She called pharmacy who made a new bag with the remaining dose that had not yet been infused (patient had received 163ml of a 305.5ml bag).A new filter line was attached below the current leaking site on the current line (which was clamped) and the new drug was ran through the new line.Medical intervention was not required.Intubation was not necessary.There were no unusual circumstances.The device was not re-sterilized or re-processed.The device was not pre-tested prior to use.Second device was not required.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.E1 initial reporter facility name: (b)(6).E1 initial reporter phone number: (b)(6).
Additional Manufacturer Narrative
A photo was returned by the customer showing the 0.2 micron filter.No leakage observed.Received one new 142540489 primary plum set for inspection.No damages or anomalies noted.The set was leak tested per product specifications.There was no leakage.The reported complaint was unable to be replicated or confirmed.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, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU
• 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: 18317660
• Report Number: 9615050-2023-00775
• Device Sequence Number: 20541133
• Product Code: FPA
• UDI-Device Identifier: 10887787006039
• UDI-Public: (01)10887787006039(17)260701(10)13684576
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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: 07/01/2026
• Device Catalogue Number: 142540489
• Device Lot Number: 13684576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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: DURVALUMAB, UNK MFR.
• Patient Sex: Female