MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5" (13 CM) APPX 0.33 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 CLAMP; STOPCOCK, I.V. SET

Catalog Number 011-MC33869

Device Problem Air/Gas in Device (4062)

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

Event Date 01/14/2023

Event Type  malfunction  

Event Description

The incident involved a 5" (13 cm) appx 0.33 ml, smallbore bifuse extension set with 2 microclave¿ clear, 2 clamps, rotating luer.The customer reported that during treatment with reanutriflex, the nurse in charge of the patient in the intensive care unit observed that the tubing of the line was filled with air although it had not been handled.There were air bubbles downnstream of the ramp.It is unknown if air bubbles come into contact with the patient.There was no air eliminator filter used because their setting complies with the icu medical assembly proposal.The pump did not trigger the air in line alarm because the air bubble was downstream of the ramp and no air observed upstream.The infusion was immediately stopped, and the device was changed.The patient's condition during the incident was chest pain, pulse 150, oxygen saturation 89%.Patient had normal constants before the incident and returned to normal after 30 minutes.There was a 30 minute delay in therapy, but there were no clinical consequence for the patient.There was an additional medical intervention for an auscultation by a doctor and prescription of a blood test.There was patient involvement but no adverse event or human harm.

Manufacturer Narrative

The device has been requested for evaluation but has not yet been received.

Manufacturer Narrative

Device returned to manufacturer 29-aug-2023.Leakage was confirmed with the microclave bonded to the green stopcock.Investigation revealed a torn seal that would result in fluid leakage and air infiltration.The probable cause is typical of access with an incompatible mating device during use.No mating devices were returned to evaluate with the mc33103 assembly.The dfu states: the microclave connector is compatible with luers with an internal diameter (id) between 1,55 mm and 2,8 mm.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 5" (13 CM) APPX 0.33 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 CLAMP
• 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: 16303074
• MDR Text Key: 308834443
• Report Number: 9617594-2023-00060
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

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 Catalogue Number: 011-MC33869
• Device Lot Number: 4914648
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• 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: FRESENIUS PUMP.; REANUTRIFLEX, UNK MFR.