MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, DR TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH 1 FOOT CABLE; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PX601

Device Problem Fluid/Blood Leak (1250)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation lab received one flothru dpt without any attached component.Dry blood was visible on the outside of dpt housing female luer.No leakage was detected from dpt unit during a leak test.Dpt zeroed and sensed pressure accurately on the pressure monitor.Multiple damages which appeared consistent with clamp marks were noticed on the lock nuts of dpt housing.No other visible damage was observed from the unit.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that csf leakage occurred around the cap on distal end of a model px601 transducer.The event happened after the patient had external ventricular drainage for more than 24 hours.The staff changed the evd system and new transducer to resolve the issue.No patient injuries reported.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH 1 FOOT CABLE
• 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 ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16675501
• MDR Text Key: 313561328
• Report Number: 2015691-2023-12083
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PX601
• Device Catalogue Number: PX601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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