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

Model Number T310682A

Device Problem Device Alarm System (1012)

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

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

The reported event of "pressure (cvp) was not correct" was not confirmed.The dpt sensor zeroed and sensed pressure accurately on the pressure monitor.The pressure reading was stable during an 8 hour pressure drift test.Electrical testing showed that both input and output impedance of the dpt sensor were within specifications.Zero-offset also met specification.No leakage or occlusion was detected from the unit during the pressure test.No visible defect was observed from the unit.The reported event was not confirmed.Although the cause of the complaint could not be determined, there was no indication of a manufacturing defect noted during the analysis.No actions will be taken at this time.510k number unknown as this was a custom defined product.

Event Description

It was reported that the central venous pressure (cvp) was not correct according to the patient status.During set up of the device, the flushing and the system worked correctly and the values were correct (10 mmhg) when the monitoring started in the operating room.However, after 30 minutes the pressure decreased to minus 17 mmhg.There was no alarm.Furthermore, all external possibilities that could have influenced the pressure were checked, as placing of the sensor level, filling and pressure (300 mmhg) of the saline, air bubbles, kinking of the line, stopcocks open/closed, but no cause was found.Replacing the device for another one solved the issue; thus the values displayed came back to 10-11mmhg.There was no allegation of patient injury.The product is available for evaluation.

• Brand Name: 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 ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: brian hurd ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5536838
• MDR Text Key: 41917978
• Report Number: 2015691-2016-01019
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/11/2016

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: T310682A
• Device Lot Number: 60130948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 03/30/2016
• 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