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

Model Number T100214A

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

We received one single dpt kit for examination.The reported event of pressure reading issue with the dpt kit was not confirmed.The dpt sensor zeroed and sensed pressure accurately on the pressure monitor.Pressure reading was also stable during 8 hour output 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 dpt kit during pressure test.No visible damage was observed from the dpt kit.Lot number was not provided, therefore, review of the manufacturing records could not be completed.The reported event was not confirmed 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.Although the cause of the complaint could not be determined, there was no indication of a manufacturing defect noted during the analysis.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.The 510k number unknown as this is a custom define product.

Event Description

It was reported that, during use in the o.R., 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.

Manufacturer Narrative

Please see related medwatch 2015691-2016-03690.

• 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: 6170641
• MDR Text Key: 62252661
• Report Number: 2015691-2016-03682
• 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,Followup
• 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: T100214A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/13/2016
• 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