MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Model Number B1479

Device Problem No Flow (2991)

Patient Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.Additional information: 8349917; manufacturing date: 8/1/2022; expiration date: 8/1/2027.6077161; manufacturing date: 7/1/2022; expiration date: 7/1/2027.

Event Description

It was reported that, on an unknown date, an 8" smallbore ext set w/0.2 micron filter, clamp, luer lock experienced clogging/obstruction of the 0.2-micron filter when administering epoprostenol to the patient (continuous intravenous/central infusion).After the filter, the clog was ultimately loosened via a 10 ml saline flush.During the incident, it was running at 2cc/min.For approximately 3 hours.Additionally, it was stated that the patient was having discomfort.The baxter pump alarm sounded for occlusion, then was flushed with 10cc saline.A new med solution bag was switched out for the old bag.It was further stated that the infusion rate was increased to 4-5cc/min.The patient required a transfer to the icu later that day.The reporter stated that it was unclear if the event contributed to the patient's worsening hypoxemia.There was a delay in therapy that was critical to the patient reported.There was no patient harm reported.No additional information is available.This is report one of two events.

Manufacturer Narrative

A single used b1479 assembly was returned for investigation.There were no visual anomalies or damage observed.The single, used b1479 assembly was successfully primed at gravity pressure with no difficulty or occlusion at any location along the fluid pathway.The complaint was unable to be replicated or confirmed with the single used sample returned for investigation.A photo was returned showing a sealed b1479 package.There were no defects or anomalies observed from the photo.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 8" SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, LUER LOCK
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16291844
• MDR Text Key: 308732921
• Report Number: 9617594-2023-00056
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

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 Model Number: B1479
• Device Catalogue Number: B1479
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 02/09/2023
• Supplement Dates FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: EPOPROSTENOL, UKN MFR.