MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX TRANSTAR KITS; PRESSURE MONITORING

Catalog Number MX9505T

Device Problem Failure to Calibrate (2440)

Patient Problem Insufficient Information (4580)

Event Date 12/12/2023

Event Type  malfunction  

Event Description

It was reported that the nurse replaced the arterial pressure sensor at 9:00 on (b)(6) 2023 and failed to perform a zero calibration several times.The monitor prompted that the arterial pressure was high and could not be zeroed.It was then replaced with a new pressure sensor and was working normally.There was patient involvement and had patient harm/adverse event reported.

Manufacturer Narrative

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.

Manufacturer Narrative

Device evaluation: a review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No trend of confirmed complaints in relation with this issue was identified.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: MEDEX TRANSTAR KITS
• Type of Device: PRESSURE MONITORING
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18539446
• MDR Text Key: 333225660
• Report Number: 9616567-2024-00014
• Device Sequence Number: 1
• Product Code: DPT
• UDI-Device Identifier: 10351688503992
• UDI-Public: (01)10351688503992(17)250919(10)4323171
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• 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: 4323171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2022
• 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