MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSDUCER, 60 INCH (152 CM), 3 ML/HR, MICRODRIP; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-0P230-01

Device Problem Disconnection (1171)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

The initial reporter phone number (b)(6).

Event Description

The event involved a transducer, 60 inch (152 cm), 3 ml/hr, microdrip where the customer reported that at the emergency resuscitation unit during infusion on (b)(6) 2024, at 06.00 pm, the tubing has spontaneously disconnected from the arterial catheter chip on the patient after about 15 days.No clinical consequences on the patient.Air could have entered the artery.Tubing was removed and changed.There was patient involvement and no adverse event/human harm.The nurse found the tubing separated from the device during treatment (device put in place 15 days previously).The product is not available for evaluation.

• Brand Name: TRANSDUCER, 60 INCH (152 CM), 3 ML/HR, MICRODRIP
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 18920622
• MDR Text Key: 337856967
• Report Number: 9617594-2024-00275
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619035624
• UDI-Public: (01)00840619035624(17)260801(10)13744652
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-0P230-01
• Device Lot Number: 13744652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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