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

Device Problem Fluid/Blood Leak (1250)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.

Event Description

It was reported that on an unknown date a primary plum set, clave secondary port, 2 clave y-sites, 0.2 micron filter, secure lock, 112 inch sets are leaking in high frequency in the chemo suites during patient use.The medication involved was paclitaxel.There were two drops on the patient, drops were absorbed onto a blue pad, the patient's skin was cleansed, and instructions were provided for laundering clothing.The chemo drug came into contact with clothing.There was unprotected chemodrug exposure to the patient.The chemo drug spill was cleaned up per facility protocol.There were no holes, cuts, tears, or any defects noted.The affected sample was attached to a tubing set with a closed system transfer device - chemolock.It was also stated that the chemo was coming out of the two circles on the back of the filter case.There was patient involvement and no patient harm.

Manufacturer Narrative

An image of the inline filter of the primary plum set was provided by the customer.Received one (1) used list #142540489 primary plum set connected to a chemolock connector.There was no damage or anomalies noted on the set either set.The returned sample was leak-tested per product specifications.There were no leaks observed.The complaint of leakage cannot be confirmed on the returned used sample.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 1/29/2024.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU
• 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: 18390052
• MDR Text Key: 331318463
• Report Number: 9615050-2023-00812
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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 Health Care Professional
• Type of Report: Followup
• Report Date: 03/07/2024

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: 142540489
• Device Lot Number: 13684576
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/24/2023
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2023
• 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: PACLITAXEL, UNK, MFR.