MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DPS DOUBLE LINE PRESSURE MONITORING KIT; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number MX9622CZ

Device Problem Unable to Obtain Readings (1516)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

Other, other text: d4: lot number, expiration date, h4: manufacturing date no information provided to date, b3: month and year of event have been provided, day is unknown.No product was made available for investigation.If the sample is made available, we will reopen the file and send investigation results in a supplemental report.Device history review not completed as no lot number was provided.

Event Description

It was reported that no pressure traces were visible, and the equipment would not zero.The customer states that the issue could possibly be the transducers.The customer has tried single and double transducers but the transducers only work in two (2) of their four (4) labs.These events occurred over three days, twice during angioplasty and once during a right heart catheter assessment.One of the case issues caused the patient to be moved to another lab which resolved the issue.The other two events can be found in (b)(6).Customer states the device is not available for return.

• Brand Name: DPS DOUBLE LINE PRESSURE MONITORING KIT
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, 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: 17638859
• MDR Text Key: 322136179
• Report Number: 3012307300-2023-08457
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K172458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MX9622CZ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention