MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR PRESSURE TRANSDUCER; PROBE, BLOOD-FLOW, EXTRAVASCULAR

Model Number MX9505T

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Insufficient Information (4580)

Event Date 03/11/2023

Event Type  Injury  

Event Description

It was reported that during the use in the icu, while connected to the exhaust according to the standard operation, it was adjusted to zero (0), infusion channel was opened and it was found that the speed was abnormal.The pressure bag was pressurized very fast without opening a key flush, and the use was stopped immediately.After discontinuation of this product it was replaced with "something else".There has been no report of patient injury or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Manufacture date are unknown, no information is available based on the reported lot number.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Manufacturer Narrative

Evaluation codes: updated.No product was returned.A video was provided for investigation.Through the analysis of the video, it was observed that the drops speed at the microdrip chamber was abnormal, however it is not clear how the stopcock and trigger assembly are manipulated.This abnormal flow rate could not be attributable to manufacturing process, to determine causal factor the involved device is required.A device history record (dhr) review reported no discrepancies during the manufacturing of the reported lot number.No action needed since current controls are adequate for the complaint reported by customer.Trends for this failure mode will be monitored and further action taken accordingly.If the device is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: MEDEX TRANSTAR PRESSURE TRANSDUCER
• Type of Device: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16683028
• MDR Text Key: 312705739
• Report Number: 3012307300-2023-03575
• Device Sequence Number: 1
• Product Code: DPT
• UDI-Device Identifier: 10351688503992
• UDI-Public: 10351688503992
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX9505T
• Device Catalogue Number: MX9505T
• Device Lot Number: 4260053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 45 KG