MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number DPTUNKNOWN

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However the complaint could not be confirmed without the completion of the product evaluation.A supplemental report will be forthcoming with the evaluation results.Lot number was not provided, therefore review of the manufacturing records could not be completed.Mdr for related complaint 2015691-2015-02763; 510k not known as the model number was not provided.

Event Description

As reported, in two dpts (disposable pressure transducer) the arterial blood pressure values provided were correct when the monitoring started in the operating room; however, the values suddenly increased when the patient was in the icu (intensive care unit).The alarm "high arterial pressure" was displayed on the monitor and the patient was treated according to the pressure values provided.Customer also verified all the connections of the device, and that the dpt was placed correctly.The patient was treated again in order to correct the therapy that was given based on inaccurate values.There was no allegation of patient injury.The sensor was changed for another one and the values displayed correctly.

Manufacturer Narrative

We received one triple dpt kit for examination.The iv tubing had be cut and part of the iv tubing with drip chamber was not returned.Priming solution was visible inside of the kit.All dpts zeroed and sensed pressure accurately on a pressure monitors.Pressure readings from all four dpts were stable during pressure drift test.Electrical testing also showed that the dpt electronic components were intact because both input and output impedances were within specifications.Zero-offset also met specification.No leakage or occlusion was detected from the kit during the pressure test.No visible defect was observed from the kit.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.

• Brand Name: DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5156916
• MDR Text Key: 28564432
• Report Number: 2015691-2015-02767
• Device Sequence Number: 1
• Product Code: DRS
• 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: Followup
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DPTUNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2015
• 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