MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V MEDEX TRANSTAR PRESSURE TRANSDUCER; PROBE, BLOOD-FLOW, EXTRAVASCULAR

Catalog Number	MX9505T
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: neither sample nor pictures were received for analysis of this complaint.The device history record of reported lot 6058629 was reviewed and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Without the return of the product a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.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.
Event or Problem Description
It was reported that an 83-year-old male patient born on 20-feb-1942 had a radial artery catheter successfully placed.After connecting the transducer, the monitor displayed 'sensor detached' and did not show the connected sensor.Upon checking, the arterial catheter pathway was patent, the pressure transducer and pressure connecting line were securely connected, and the pressure tubing and pressure module were in good condition.After replacing the transducer, all displays returned to normal.No patient harm was reported.

• Brand Name: MEDEX TRANSTAR PRESSURE TRANSDUCER
• Common Device Name: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6250 shier rings road,; dublin, OH 43016 ; 2247062300
• MDR Report Key: 24507917
• Report Number: 1526863-2026-00059
• Device Sequence Number: 9982019
• Product Code: DPT
• UDI-Device Identifier: 10351688503992
• UDI-Public: (01)10351688503992(17)271119(10)6058629
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K942377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MX9505T
• Device Lot Number: 6058629
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male