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

Model Number PX260

Device Problem Material Separation (1562)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/02/2023

Event Type  malfunction  

Event Description

As reported, during use in patient with this disposable pressure transducer (dpt), pressure line disconnected from patient side and the alarm "pa disconnected" was triggered.When user arrived, a stain of blood of about 300 ml was noticed.The patient was mobilizing his arm and the bracelet containing the cell moved.The dpt was fixed to the patient arm using a bracelet (see picture attached).The hemoglobin was confirmed to be correct and no blood transfusion was necessary.There was no allegation of patient injury.The device was not available for evaluation.

Manufacturer Narrative

The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.No product was returned for evaluation; the product was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.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.

Manufacturer Narrative

One image provided was reviewed.The image showed a dpt attached with a cuff to a patient's arm.Based on this image, the defect reported of regarding disconnected pressure tubing could not be confirmed.Based on further engineering evaluation, there are manufacturing 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: 17928984
• MDR Text Key: 325588043
• Report Number: 2015691-2023-16780
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PX260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2023
• 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
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 78 KG