MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, 213 CM (84"), DISPOSABLE TRANSDUCER, 03 ML SQUEEZE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-46115-68

Device Problem Disconnection (1171)

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

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is not yet received.Additional contact information: (b)(6).

Event Description

The event involved a transpac® iv monitoring kit, 213 cm (84"), disposable transducer, 03 ml squeeze flush device, macrodrip un-bonded.The customer reported that the connection was suspected to be broken/defective sensor.The customer tried to change tram module 2 times, and didn't work, then they tried to change invasive cable 2 times, and also didn¿t work.The monitor kept showing disconnection, no reading or waveform shown.Further information was received stating that the event was the whole time from priming until insertion of arterial line.There was patient involvement but no patient harm was reported.

• Brand Name: TRANSPAC® IV MONITORING KIT, 213 CM (84"), DISPOSABLE TRANSDUCER, 03 ML SQUEEZE
• 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: 18943229
• MDR Text Key: 338151823
• Report Number: 9617594-2024-00300
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619096830
• UDI-Public: (01)00840619096830(17)251001(10)10618928
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-46115-68
• Device Lot Number: 10618928
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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