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 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not yet been received.Without the returned device, a probable cause is unable to be determined.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.

Event Description

The complaint/event involved a transducer, 60 inch (152 cm), 3 ml/hr, microdrip.The tubing of the device reportedly disconnected from the arterial catheter chip.The customer stated that air could have potentially entered the patient's artery, but there were no clinical consequences for this patient.The tubing was removed and changed.There was no adverse event or human harm associated with this complaint/event.

• 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: 18859612
• MDR Text Key: 337188467
• Report Number: 9617594-2024-00240
• 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: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• 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
• Treatment: UNSPECIFIED ARTERIAL CATHETER, MFR UNK