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

Model Number T005002A

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Manufacturer Narrative

The product is not expected to be returned for analysis since it was discarded at the hospital, however, images were provided for evaluation.Two pictures were reviewed.Customer report of tubing detachment was confirmed.Images showed a close up on a male connector of a pressure line.The male connector was noticed completely detached from pressure tubing.The lot number was not provided.Therefore, the device history record (dhr) could not be reviewed.An engineering evaluation will be completed to consider any potential factors that may have contributed to this complaint.A supplemental report will be sent with the investigation results.H3 other text : device was discarded by the customer.

Event Description

As reported, during use in patient with this pressure monitoring set, the luer from pressure tubing connector detached, causing minimal blood loss.No additional intervention nor special treatment was needed.There was no patient injury.Patient demographics were unknown.The device was not available for evaluation.

Manufacturer Narrative

Based on further engineering investigation, it could be determined that the reported malfunction could be related to the solvent bonding process during the device manufacturing.An acknowledgment related to the complaint was provided to the manufacturing personnel.Nevertheless, there are controls to avoid potential causes related to the reported malfunction.

• 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: 16783416
• MDR Text Key: 314084863
• Report Number: 2015691-2023-12454
• 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: 06/01/2023

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 Operator: Health Professional
• Device Model Number: T005002A
• Device Catalogue Number: T005002A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 06/01/2023
• 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