MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number T001691M

Device Problem Incorrect Measurement (1383)

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

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

One disposable pressure transducer (dpt) was received by our product evaluation laboratory for a full evaluation.Customer report of pressure issue was confirmed.The dpt did not zeroed nor sense pressure on a pressure monitor.The electrical testing showed that input impedance was within specifications, but output impedance was out of specifications.A crack was observed on the sensor chip inside the dpt.No visible damage/defect was observed at solder joints, dpt cable connector, and cable of the dpt.An engineering investigation will be performed in order to consider any potential factors that may have contributed to this complaint.A supplemental report will be submitted accordingly upon investigation completion.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 part of this monthly review.

Event Description

As reported, during use in patient of this dpt (disposable pressure transducer) and after a successful priming and zeroing of the device, this dpt provided systolic arterial blood pressure values 60 mmhg higher (170-90 mmhg) than the non-invasive cuff (110-60 mmhg) placed on the same arm.During inflation of the brachial cuff, the waveform changed and even disappeared when it was fully inflated, returning during deflation to a normal state.Between non-invasive measurements, the waveform was normal, but the arterial line pressure remained constantly higher.No alarms or error messages were displayed and the patient was not treated according to these incorrect values.It was also noticed that the difference increased with higher pressure measurements.The device was replaced with a new one to solve the problem.Patient demographics unable to be obtained.There was no allegation of patient injury.The device was returned for evaluation.

Manufacturer Narrative

Added information to section d4 (expiration date), h4 (device manufacturer date) and h6 (type of investigation) updated section h6 (investigation findings) and h6 (investigations conclusions).The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Based on further engineering investigation, there is no evidence to conclude that the reported issue could be caused during the manufacturing process.There are stablished process controls to prevent the occurrence of the reported malfunction.The potential root cause could be associated to supplier.A personnel acknowledgment related to this complaint was provided to the manufacturing personnel and the supplier was notified regarding the condition.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• 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: 18281313
• MDR Text Key: 329887160
• Report Number: 2015691-2023-18144
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

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: Health Professional
• Device Model Number: T001691M
• Device Lot Number: 64471014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• 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