MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 31" (79 CM) APPX 3.3 ML, EXT SET W/CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number	B1154
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The device involved is a 31" (79 cm) appx 3.3 ml, ext set w/clamp, rotating luer where it was reported that a general anesthesia was being delivered using intravenous medication via a syringe and infusion set in a syringe pump.The infusion set developed a leak, resulting in anesthetic solution being pumped out of the system and onto the floor and not into the patient.This was not noticed.Incident impact is sudden, uncontrolled partial emergence from anesthesia in the middle of a neurosurgical procedure.Therapy was resumed.There was no long-term patient impact reported.There was patient involvement but no patient harm.No additional information was provided.
Additional Manufacturer Narrative
The complaint of leaks can not be confirmed based on the the video provided by customer because the leaks appear to be coming from the non-icu product and physical sample was no received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history report (dhr) for lot 6032751 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: 31" (79 CM) APPX 3.3 ML, EXT SET W/CLAMP, ROTATING LUER
• Common Device Name: 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: 17030205
• Report Number: 9617594-2023-00219
• Device Sequence Number: 17757221
• Product Code: FMG
• UDI-Device Identifier: 00887709000599
• UDI-Public: (01)00887709000599(17)270601(10)6032751
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

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
• Operator of Device: Health Professional
• Device Model Number: B1154
• Device Catalogue Number: B1154
• Device Lot Number: 6032751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2022
• 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: SYRINGE, MFR UNK.; UNSPECIFIED GENERAL ANESTHESIA, MFR UNK.
• Patient Sex: Unknown