MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE¿ CLEAR NEUTRAL CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MC100

Device Problem Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 12/17/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The incident involved a microclave¿ clear neutral connector.It was reported that the microclave¿ clear neutral connector was attached to iv tubing multiport set infusing iv medications when it failed and began leaking.The leak occurred on the body of the clave itself in a circumferential fashion, not in the tubing, and there were no inline filters.Additionally, it was stated that there were no obvious holes, cuts, defects visible to the naked eye on the clave, but the leak was obvious under normal infusion pressures.The setup was a standard iv drip with fluid carrier, i.E.Primary pump tubing, connected to a q2 multiport extension set, connected to the clave, connected to a peripherally inserted central catheter (picc) line.The multiport had 2 vasoactive drips (levophed and vasopressin), analgesia (fentanyl), sedative (propofol), and a paralytic (vevuronium) connected to the side ports and 0.9 normal saline carrier.It was reported that the tubings were not replaced; only the leaking clave was exchanged and therapy was continued.It was further stated that the patient was critically ill and became very unstable with decreased blood pressure and oxygen saturation.Stat iv fluid bolus and ventilator changes were required to maintain the patient until the problem was discovered and resolved.The patient was in acute multi-organ failure, in the prone position, paralyzed and sedated.During the event, the patient woke up started moving and became unstable.

Manufacturer Narrative

The complaint of leaks cannot be confirmed.Received one photo showing the microclave with a red luer attached the male end of the device.No damages or anomalies can be observed in the photo provided.No samples were returned for evaluation.The device history review (dhr) for lot 13475803 was reviewed and no non conformities were found that would have led to the reported complaint.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.

• Brand Name: MICROCLAVE¿ CLEAR NEUTRAL CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 16240189
• MDR Text Key: 308667091
• Report Number: 9617594-2023-00037
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00887709037151
• UDI-Public: (01)00887709037151(17)271101(10)13475803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC100
• Device Catalogue Number: MC100
• Device Lot Number: 13475803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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: 0.9 NORMAL SALINE, MFR UNK; FENTANYL, UNK MFR; LEVOPHED, UNK MFR; PRIMARY IV TUBING SET, MFR UNK; PROPOFOL, UNK MFR; Q2 MULTIPORT EXTENSION SET, MFR UNK; VASOPRESSIN, UNK MFR; VEVURONIUM, UNK MFR
• Patient Sex: Female