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	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on 22-jul-2024 to 25-jul-2024 involving a primary plum set, clave secondary port, 2 clave y-sites, 0.2 micron filter, secure lock, 112 inch it was stated that the product was leaking with a medication of doxorubicin.The event occurred during infusion.The doxorubicin is in epoch (etoposide, vincristine, doxorubicin).Rituximab with another research study medication was dispensed with primary plum set tubing and a spiros attached on the end of the primary tubing set.Leakage occurred due to the spiros disengaging from the primary tubing.Another incident with the spiros was checked before infusing and it was able to be removed from the primary tubing.The spiros was replaced with a new spiros and connected to the primary line.The spiros was checked before infusing and it was able to be removed from the primary tubing.The spiros was replaced with a new spiros and connected to the primary line.There was patient involvement, no patient harm but there was a delay in therapy because they needed to stop due to leakage.
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint of leakage could not be confirmed by investigation.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: 20058490
• Report Number: 9615050-2024-00632
• Device Sequence Number: 15363579
• Product Code: FPA
• UDI-Device Identifier: 10887787006039
• UDI-Public: (01)10887787006039(17)270101(10)13817515
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2024

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: 142540489
• Device Lot Number: 13817515
• 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: 07/25/2024
• Initial Report FDA Received Date: 08/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2024
• 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: DOXORUBICIN, MFR UNK; SPIROS, MFR UNK
• Patient Sex: Unknown