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

Model Number MP5100(TW)_

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

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

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Unfortunately, we did not receive the sample for examination in our product evaluation laboratory.Without return of the product, we are unable to perform a complete investigation into the root cause of the reported event.At this time, we cannot confirm the reported issue.

Event Description

It was reported that although it was not connected to the patient and there was no pressure, the monitor showed the value over 300.The kit was to be used for measuring the pressure in the bypass circuit.The expected value was 0 (zero).Normal shape of the waveform was shown and the value and the waveform was not matched.The device was exchanged and the problem was solved.It is unknown if the device zeroed before use.The customer did not provide information on whether the error message was observed or not, nor if there were any occlusion, leakage or kinks.The sample of tracing was not available.There were no patient complications reported.The device was discarded by the hospital therefore it is not available for evaluation.Occurrence date is unknown.

• 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; haina. san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5308057
• MDR Text Key: 33834460
• Report Number: 2015691-2015-03426
• 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: 12/04/2015

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: MP5100(TW)_
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/17/2015
• 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