MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, MACRODRIP; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number 42800-03

Device Problem Separation Problem (4043)

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

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, however has not been received.

Event Description

The event occurred on an unspecified date and involved a transpac¿ it monitoring kit, 60" pressure tubing, 3ml flush device, macrodrip, where it was reported that the kit came apart at the transducer connector and had to be replaced.There was no patient harm reported.

Manufacturer Narrative

No product samples, videos, or photographs were returned for investigation.The lot history was reviewed and there were no nonconformities found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.The reported complaint cannot be confirmed.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, MACRODRIP
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17183749
• MDR Text Key: 318052263
• Report Number: 9617594-2023-00262
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00887709097582
• UDI-Public: (01)00887709097582(17)251101(10)11746423
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42800-03
• Device Catalogue Number: 42800-03
• Device Lot Number: 11746423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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