MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR 84 INCH SINGLE MONITORING KIT; PROBE, BLOOD-FLOW, EXTRAVASCULAR

Catalog Number MX9505T

Device Problem Unable to Obtain Readings (1516)

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

Event Date 01/07/2024

Event Type  malfunction  

Manufacturer Narrative

H3 - other: device not returned to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that during a gastric rupture repair on the patient.After performing an invasive blood pressure puncture, when connecting the pressure sensor, the monitor cannot display the invasive blood pressure waveform.Because of this, the patient's vital signs cannot be effectively monitored during surgery.After replacing the motion sensor, the monitor displayed normal waveforms.It is unknown if the product will be returned.There was patient involvement, but no harm/adverse effect reported.

Manufacturer Narrative

No device was returned for investigation.Therefore, we are unable to confirm the reported complaint.If we receive the product, the investigation will be reopened and evaluated.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: MEDEX TRANSTAR 84 INCH SINGLE MONITORING KIT
• Type of Device: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 9124 polk ln, suite 101; olive branch MS 38654
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18703704
• MDR Text Key: 335364465
• Report Number: 3008818980-2024-00005
• Device Sequence Number: 1
• Product Code: DPT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K942377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX9505T
• Device Lot Number: 4323165
• 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: 10/20/2022
• 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
• Patient Age: 92 YR
• Patient Sex: Male