MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 14687-15

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2023

Event Type  malfunction  

Event Description

The event involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch where it was reported during normal saline flushing, the pump alarmed.The healthcare provider checked the intravenous (iv) set and found leakage on filter vent.Leaked solution was noted on pump as well.The set was replaced, and therapy resumed.The event was noted after chemotherapy drug infusion completed and during saline flushing.There was no chemo drug exposure and no chemotherapy spilled.There was patient involvement, but no patient harm.

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.E1 intial reporter phone number: ext.(b)(6).

Manufacturer Narrative

Received one used 14687-15 primary plum set for inspection.As received, the air filter on the vent plug juncture was wetted out with prior infusate.The product was tested per product specification.There was a leak observed from the filter on the vent plug juncture with the cap open.The leak appeared to seep through the filter vent material from various locations.The reported complaint of leakage can be confirmed.The probable cause of leakage is due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH
• Type of Device: 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: 18400639
• MDR Text Key: 332494503
• Report Number: 9615050-2023-00815
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)260401(10)13615164
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 14687-15
• Device Lot Number: 13615164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NORMAL SALINE, UNK MFR.; UNSPECIFIED CHEMOTHERAPY, UNK MFR.; UNSPECIFIED INFUSION PUMP, UNK MFR.