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

Model Number PXVPL0029

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2023

Event Type  malfunction  

Manufacturer Narrative

The device involved in this case was received by our product evaluation laboratory for a full evaluation.During the evaluation, the pressure tubing had been completely detached from bond joint with vamp plus reservoir stopcock.Mating detached pressure tubing was not returned.Indication of bonding material was evident at the reservoir stopcock bond surface area.The leakage was most likely due to the detached connection.No other visible damage was observed from the sensor.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 and when pressurizing this truwave set, there was blood leakage (less than 1ml) on connectors that shall be glued.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

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, regarding the failure mode of bond of tubing to reservoir detached, the root caused could be concluded to be relate to the solvent bonding process during the device manufacturing.A personnel acknowledgment was provided to the manufacturing personnel.Additionally, regarding the failure mode of iv tubing cut, it could be concluded that there are manufacturing controls to detect this type of defect during the manufacturing process.Furthermore, it was concluded that this kind of cut cannot occur during the manufacturing process.This is more likely a straight cut with a tool like scissors, and no tool that could cause the kind of cut is available during the process.

• 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: 17236454
• MDR Text Key: 318208544
• Report Number: 2015691-2023-14292
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: PXVPL0029
• Device Catalogue Number: PXVPL0029
• Device Lot Number: 64291756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• 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