MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX TRANSTAR ARTERIAL PRESSURE MONITOR KIT; PROBE, BLOOD-FLOW, EXTRAVASCULAR

Catalog Number	MX7827
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: month and year of event have been provided, day is unknown.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 or Problem Description
It was reported that the tubing set off the high-pressure alarm in the pump.The alarm could not be cleared no matter how many times they increased the pressure limits.There was patient involvement, but no patient harm/adverse event reported.The outcome of the event was reported as ongoing.
Additional Manufacturer Narrative
D9: date returned to mfg.: 1/22/2024.H3 and h6.Evaluation codes: updated.Two samples used outside its original package were received for investigation.The complaint was not confirmed for the failure mode reported ¿tubing set off the high-pressure alarm in the alaris large volume pump that couldn't be cleared¿.Through the device analysis executed it was found that the returned sample passed the electrical test.Awareness for failure ¿tubing set off the high-pressure alarm in the alaris large volume pump that couldn't be cleared¿ was given to personnel who perform the assembly process.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: MEDEX TRANSTAR ARTERIAL PRESSURE MONITOR KIT
• Common Device Name: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel aleman km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18527568
• Report Number: 9616567-2024-00010
• Device Sequence Number: 6412187
• Product Code: DPT
• UDI-Device Identifier: 10351688505187
• UDI-Public: (01)10351688505187(17)261002(10)4435876
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2024

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 Expiration Date: 10/02/2026
• Device Catalogue Number: MX7827
• Device Lot Number: 4435876
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALARIS LARGE VOLUME PUMP
• Patient Sex: Unknown