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 complaint could not be confirmed.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history report (dhr) for lot 13744652 was reviewed and no non conformities were found that would led to the reported complaint.

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.

• 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: 18961040
• MDR Text Key: 338379694
• Report Number: 9617594-2024-00322
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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: 02/22/2024
• 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