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

Model Number T005048B

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.Lot number was not provided; therefore review of the manufacturing records could not be completed.Pressure readings can change quickly and dramatically because of loss of proper calibration, loose connection, or air in the system.Abnormal pressure readings should correlate with the patient¿s clinical manifestations.Significant distortion of the pressure waveform can result from air bubbles in the setup.Poor dynamic response can be caused by air bubbles, clotting, and excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.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.No corrective or preventative actions are required at this time.510 k number unknown as this is a custom define product.Please see related medwatch 2015691-2016-03682.

Event Description

It was reported that, during use in the or, the disposable pressure transducer (dpt) displayed 120/60 on the monitor.The patient was transferred to the icu with the same dpt, philips monitor and cable.In the icu the pressure displayed 170/80.The patient was given antihypertensive medications but the patient¿s blood pressure did not change.The philips monitor, cable and dpt were changed out, but the pressure measurement remained the same.The nibp cuff showed values that were 40-50mmhg lower than the invasive pressure.No error or alarm message was seen on the monitor.No patient complications were reported.Inquired of patient demographics, unable to be obtained.The device was discarded at the hospital.

• Brand Name: CUSTOM DEFINED 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-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 6171510
• MDR Text Key: 62331285
• Report Number: 2015691-2016-03690
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 11/21/2016

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: T005048B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: No
• 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