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

Model Number PX260

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

One dpt (disposable pressure transducer) was received by our product evaluation laboratory for a full examination.The report of leakage issue was confirmed.As received the pressure tubing was found completely detached from bond joint with male connector which was connected to the female stand-alone stopcock connector.Leakage is most likely due to the detached connection.Indications of what appeared to be bonding material were evident on tubing bond surface area.Tubing od was measured near the point of detachment and it was within specification.No other visible damage or inconsistency was found to the returned kit.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.

Event Description

As reported, during use in patient with this pressure monitoring set, there was a solution leakage at the pressure line.The problem was solved replacing the device for a new one.There was no allegation of patient injury.The device was received for evaluation.Patient demographics unable to be obtained.

Manufacturer Narrative

Further investigation was performed by the engineers in the manufacturing site and it was determined that the failure was likely due to manufacturing.After the complaint assessment done, it can be concluded that the lack of solvent is the most probable cause of the defect, associated to no proper executions of solvent bonding process.The manufacturing personnel has been notified about this condition.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.

• 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 ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16875424
• MDR Text Key: 314625910
• Report Number: 2015691-2023-12770
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 64465432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• 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