MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number MC9013

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/10/2024

Event Type  malfunction  

Event Description

The event involved a 14" ext set w/0.2 micron filter, clave¿ clear, clamp, rotating luer where it was reported there was a leak during infusion of paclitaxel.The dose was administered at 1610, the patient got up at 3:30 a.M.And placed their hand on the filter and found it wet.It was stated the fluid was "bubbling from the divot." the nurse handled clean up and replaced the filter.The second incident occurred at 2:30 pm.When the last of the chemotherapy was being flushed.Patient was in bed and noticed fluids coming out of divot.Nurse decided to discard the last 6ml of treatment left in bag.The patient's gown was replaced.The set up was the filter extension was placed after the paclitaxel through secondary tubing directly to the patient line.Paclitaxel (0.77mg/ml) running at 26.3ml/hr, leak occurred roughly 11 hours after start.Furthermore, it was reported that there were 2 incidents for this dose, one occurred at around 0330 on (b)(6) 2024 and the filter was replaced and then it occurred again at 1430 on (b)(6) 2024.Tubing was replaced and therapy resumed.There was patient involvement, however, no report of harm and no delay in therapy reported.This captures the second of two occurrences.

Manufacturer Narrative

Photo provided showing inline filter with arrow indicating the outlet filter vent as the area of leakage.Without the return of the device a probable cause is unable to be determined.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Possible lot number: 13870091 manufacturing date: 1/1/2024 expiration date: 1/1/2029.D9 device returned to manufacturer should be blank.

• Brand Name: 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19075619
• MDR Text Key: 340479865
• Report Number: 9617594-2024-00385
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC9013
• Device Lot Number: PLOT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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