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

Model Number T001645A

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2015

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 and device history results.

Event Description

As reported, the dpt (disposable pressure transducer) gave the wrong pressure values.Despite being zeroed several times, high pressure values were provided that did not correspond to the clinical patient status.The patient was given antihypertensive medication twice based on these inaccurate values.The inaccurate values were confirmed by measuring the blood pressure manually with the cuff.The issue was solved by changing the dpt.There were no consequences to the patient.

Manufacturer Narrative

We received one single dpt kit for examination.No priming solution was visible inside of the kit.Iv and vented caps were still attached to the kit.The dpt zeroed and sensed pressure accurately on a pressure monitor.Pressure reading was also stable during 8 hours pressure drift test.Electrical testing showed that the dpt electronic components were intact because both input and output impedance 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.A review of the manufacturing records indicated that the product met specifications upon release.

• 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: 5078097
• MDR Text Key: 25833372
• Report Number: 2015691-2015-02413
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2017
• Device Model Number: T001645A
• Device Lot Number: 60036725
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2015
• 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