MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX TRANSTAR 84 INCH SINGLE MONITORING KIT; PROBE, BLOOD-FLOW, EXTRAVASCULAR

Catalog Number MX9505T

Device Problem Unable to Obtain Readings (1516)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported that in the past two months, in the icu, the anesthesiology department has been experiencing problems such as no waveforms no data being output.In some cases, there are no waveforms after half an hour of use.Sometimes the anesthesiology department will see several cases a day, it appeared that the pressure test suddenly failed to produce waveforms during the operation.The above situations have occurred very frequently.Five product faults reported under (b)(6).Adverse effects to the patient have not been 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.E1 initial reporter phone number : (b)(6).

Manufacturer Narrative

Investigation summary: five used samples outside their original package were received at monterrey site for investigation.Electrical testing performed.The five (5) returned samples were found accepted during the electrical test.Vacuum testing performed.Three (3) out of five (5) of the returned samples were found rejected during testing.Air leak testing performed.The five (5) returned samples were found accepted during testing.Water leak testing performed.The five (5) returned samples were found accepted during testing as the parts did not leak.Red ink testing performed.The five (5) returned samples were tested by introducing red ink using a syringe, to identify the cause of the leak found during air and vacuum testing.The five (5) parts did not exhibit leakage condition.The two (2) returned samples were visually inspected by removing cover to verify the solder appearance.Solder application was observed to be correctly applied.Complaint is confirmed for the failure mode reported ¿the anesthesiology department has been experiencing problems such as no waveforms no data being output¿ through the device analysis executed it was found that three (3) returned samples failed vacuum test.A capa was initiated to investigate root cause of leak and electrical issues on transtar assembly a950-02.The device history record of reported lot 4308962 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.Dhr of lots 4316713, 4318860 and 4318861 used subassy a950-02, which is related to condition reported was reviewed.As part of the process the product is inspected 100% electrically.Results of these lots were reviewed and were found within specifications.

• Brand Name: MEDEX TRANSTAR 84 INCH SINGLE MONITORING KIT
• Type of Device: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• 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: 18771887
• MDR Text Key: 337000124
• Report Number: 9616567-2024-00031
• 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,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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: 4308962
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2022
• 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