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

Model Number T001691M

Device Problems Fluid/Blood Leak (1250); Output above Specifications (1432)

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

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Unfortunately, we did not receive the sample for examination in our product evaluation laboratory.Without return of the product, we are unable to perform a complete investigation into the root cause of the reported event.At this time, we cannot confirm the reported issue.

Event Description

As reported, this dpt (disposable pressure transducer) provided systolic pressures values 30 mm/hg higher than the values provided by a non-edwards, non-invasive pressure cuff (arm band).The usual process was followed by checking the line, pulse flushing using the reservoir with saline solution to remove potential occlusions at the cannula.However, the saline solution squirted out of the port.Finally, the patient was treated using a flotrac sensor.There was no allegation of patient injury.Unfortunately, the sample is not available for evaluation as it was discarded by the customer.

• 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: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5592453
• MDR Text Key: 44023822
• Report Number: 2015691-2016-01304
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2016

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: T001691M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2016
• Initial Date FDA Received: 04/20/2016
• 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