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

Model Number PX12N

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2014

Event Type  malfunction  

Event Description

This event took place on a pre-term infant with a significant heart defect that was not conducive to life, therefore the child was dnr status.It was reported that the stopcock was turned to the off position but blood flowed out of the catheter through the stopcock.Attempt to reposition the stopcock resulted in no change.The tubing was removed from the patient.The patient required a blood transfusion, but this was planned prior to the blood loss and was not related to the stopcock issue.

Manufacturer Narrative

The device evaluation is anticipated.However, at this time the complaint could not be confirmed without the product.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.A supplemental report will be sent with the final investigation results.

Manufacturer Narrative

After multiple attempts to the customer for product return were unsuccessful, were are submitting the supplemental as no product return.

• Brand Name: DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4512795
• MDR Text Key: 5492304
• Report Number: 2015691-2015-00294
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2015

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: PX12N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2015
• Initial Date FDA Received: 02/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/19/2015
• 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