MAUDE Adverse Event Report: DISPOSABLE PRESSURE TRANSDUCER KIT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PXVPL2284

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation.The lot number was not provided thus a device history record was not reviewed.Ongoing investigation is being conducted to determine if user or procedural factors could have played a part in this issue.

Event Description

It was reported that the arterial line setups are inaccurate.The waveform appears under dampened and the result is a falsely elevated systolic blood pressure.This error in monitoring frequently leads to the overtreatment of systolic hypertension.Investigation is ongoing to determine the types of mistreatment, any patient injury and the number of patients involved.Patient demographics have been requested.

Manufacturer Narrative

Device evaluation was anticipated, however, additional follow up with the hospital confirmed that the device is not available for return.A meeting with the doctor, sales representative, and clinicians was conducted to understand the details of the complaint.During this meeting it was determined that 24 inch extension tubing is added the custom kit at the facility.The ifu states poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors, like excessive tubing lengths may have contributed to the event.The lot/serial number was not provided thus a device history record was not reviewed.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.

• Brand Name: DISPOSABLE PRESSURE TRANSDUCER KIT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• MDR Report Key: 12478687
• MDR Text Key: 271710472
• Report Number: 2015691-2021-05201
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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
• Device Operator: No Information
• Device Model Number: PXVPL2284
• Device Catalogue Number: PXVPL2284
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 10/05/2021
• Supplement Dates FDA Received: 10/29/2021
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1