MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE DISPOSABLE PRESSURE TRANSDUCER; PRESSURE MONITORING SET, TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Model Number PX260

Device Problem Inaccurate Information (4051)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

It was further informed that the device was not available for evaluation since it was discarded at hospital.However, an engineering evaluation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.

Event Description

As reported, during use in patient with this pressure monitoring set, incorrect diastolic (20-25mmhg) and slightly underestimated systolic (100-110mmhg) measurements were obtained.The waveform obtained was normal.Initially, this was corrected recalibrating the device.Shortly afterwards, the blood pressure value was underestimated again, which led to an increase in the noradrenaline infusion (0.5 ug/kg/min).Finally, a new "zero" calibration revealed severe iatrogenic hypertension due to the excessive increase in noradrenaline.After this, the device was replaced and the issue was solved.This episode lasted 20 minutes.No further treatment was required to correct the hypertension, and there was no allegation of patient injury.The device was not available for evaluation.

Manufacturer Narrative

The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: PRESSURE MONITORING SET, TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16782660
• MDR Text Key: 313738070
• Report Number: 2015691-2023-12444
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

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 Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 64403632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2022
• 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
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 160 KG