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

Catalog Number 011-C3300

Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)

Patient Problems High Blood Pressure/ Hypertension (1908); Irritability (2421)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

The incident involved a clave neutral connector.The reporter stated that the patient returned to the ward at 14:20 on (b)(6) 2023 after completing surgery.The patient was in a shallow coma and continued to use a ventilator to assist breathing, and was given symptomatic supportive treatment such as intravenous sedation, analgesia, and maintenance of blood pressure.At 14:40, the patient experienced irritability, man-machine confrontation, elevated blood pressure, and a risk of revasculosis.Therefore, the doctor strengthened sedation and analgesia, and adjusted antihypertensive drugs to maintain blood pressure.When the nurse adjusted the infusion, it was found that the infusion joint leaked fluid and blood, resulting in insufficient drug dosage into the patient's body, resulting in restlessness of the patient, man-machine confrontation, increased blood pressure, and the risk of rebleeding and catheter withdrawal.The product was replaced immediately.After treatment, the patient was quiet and the blood pressure was controlled within the specified range.There was patient involvement but no report of patient harm.

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.Additional contact: (b)(6).

• Brand Name: CLAVE¿ 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17772903
• MDR Text Key: 323716596
• Report Number: 9617594-2023-00727
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K970855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-C3300
• Device Lot Number: 5532966
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• 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: INTRAVENOUS SEDATION, MFR UNK.; UNSPECIFIED ANALGESIA, MFR UNK.; UNSPECIFIED ANTIHYPERTENSIVE DRUGS, MFR UNK.
• Patient Age: 30 YR
• Patient Sex: Male