MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CUSTOME DEFINED PRODUCT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number T001657A

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

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 01/12/2015

Event Type  Injury  

Event Description

The patient became increasingly hypertensive during the shift.An ace inhibitor was prescribed and given with little effect.Amlodipine was given with minimal effect.The patient¿s blood pressure was checked using a non-invasive cuff and the difference between that of the transducer and the cuff was clinically significant.Trouble-shooting was completed and cables were changed out with no change noted.Transducer set was changed and the problem was solved.

Manufacturer Narrative

We received one single dpt without any attached component for examination.The dpt zeroed and sensed pressure accurately on a pressure monitor.Pressure was stable during 8 hour 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 noticed from the dpt during pressure test.No visible defect was observed from the returned dpt.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: CUSTOME DEFINED PRODUCT
• 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: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4495428
• MDR Text Key: 5499702
• Report Number: 2015691-2015-00258
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2016
• Device Model Number: T001657A
• Device Lot Number: 59833451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2015
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2014
• 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
• Patient Outcome(s): Other