MAUDE Adverse Event Report: PRESSURE MONITORING SET (W/TRUWAVE DISPOSABLE PRESSURE TRANSDUCER & VAMP PLUS); CATHETER, CONTINUOUS FLUSH

Model Number DPTUNKNOWN

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

Follow up is on going to clarify whether the device is available for evaluation.An investigation has been initiated to consider any potential factors that may have contributed to this complaint.A supplemental report will be forthcoming with the evaluation results.The exact lot number was unknown, therefore review of the manufacturing records could not be completed.

Event Description

As reported, while testing to check the pressure difference measured by pressure transducers from different manufacturers, with the edwards disposable pressure transducer (dpt) with vamp, the arterial pressure measured 191/59 (93) while the non-invasive blood pressure measured 142/70 (90).Patient demographics requested but were not provided.

Manufacturer Narrative

It was confirmed that the device was not available for evaluation.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 may have contributed to the event.Per the ifu: poor dynamic response can be caused by air bubbles, clotting, and excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.The assembly may be tested for dynamic response by observing the pressure waveform on an oscilloscope or monitor.Bedside determination of the dynamic response of the catheter, monitor, kit and transducer system is done after the system is flushed, attached to the patient, zeroed and calibrated.A square wave test may be performed by pulling the snap tab device and releasing quickly.Pressure readings can change quickly and dramatically because of loss of proper calibration, loose connection, or air in the system.Abnormal pressure readings should correlate with the patients clinical manifestations.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.H3 other text : device not available for evaluation.

• Brand Name: PRESSURE MONITORING SET (W/TRUWAVE DISPOSABLE PRESSURE TRANSDUCER & VAMP PLUS)
• Type of Device: CATHETER, CONTINUOUS FLUSH
• MDR Report Key: 12445210
• MDR Text Key: 270537707
• Report Number: 2015691-2021-05071
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K181684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DPTUNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2021
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1