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

Model Number TC2739SB01_

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2016

Event Type  malfunction  

Manufacturer Narrative

Received one flothru dpt with stopcocks at both ends.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Examination revealed that the dpt zeroed and sensed pressure accurately on the pressure monitor.The pressure values did not show any type drift during the output drift test and met specifications.The electrical testing also showed that the dpt electronic components were intact because both input impedance and output impedance were within specifications.The zero-offset also met specification.No visible defect was found from dpt cable connector.No further actions will be taken at this time.

Event Description

It was reported that arterial pressure indicated on the nihon koden monitor was unstable and appeared to be drifting.There were no occlusions, leaks nor kinks observed from the kit.Zeroing was also performed without any issues before use.The cable was exchanged but the issue was not resolved.Finally, the dpt was exchanged and the issue was solved.Information such as the actual value, expected value, shape of the waveform, and if the waveform and value match or not were not provided.The patient was not treated based on the incorrect value, and no patient complications reported.

• Brand Name: CUSTOM DEFINED PRODUCT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; irvine ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer Contact: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5903749
• MDR Text Key: 53039319
• Report Number: 2015691-2016-02603
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/05/2016

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: TC2739SB01_
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2016
• Initial Date Manufacturer Received: 08/05/2016
• Initial Date FDA Received: 08/25/2016
• 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