MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR FLOTRAC, VAMP; FLOTRAC SENSOR W/ VAMP ADULT

Model Number	MHD6AZ5
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.The dhr could not be completed as a lot or serial number was not provided.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
Event or Problem Description
It was reported during use that mhd6az5 flotrac sensor with vamp adult was used on a patient and the diastolic was in the 20s on the a line but the upper arm cuff diastolic was in the 70 to 80s.The waveform was perfect on the a line and the square wave test was good.They re zeroed and nothing changed so they decided to change out the transducer completely and it matched the nibp cuff right away.There was no patient injury.
Additional Manufacturer Narrative
The mhd6az5 flotac sensor was returned for evaluation.Customer report of pressure reading issue was unable to be confirmed during product evaluation.No visible damage was observed from flotrac unit.Flotrac and dpt sensors of flotrac unit zeroed and sensed pressure accurately on hemosphere monitor.No error message was observed on hemosphere monitor and pressure monitor.Pressure did not show any drift during output drift testing and met specification.There was no defect found.An engineering evaluation was completed to assess for any manufacturing related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect since the device failure was not able to be confirmed.

• Brand Name: FLOTRAC, VAMP
• Common Device Name: FLOTRAC SENSOR W/ VAMP ADULT
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: erika bonilla ; one edwards way; irvine, CA 92614
• MDR Report Key: 20252181
• Report Number: 2015691-2024-07207
• Device Sequence Number: 20999422
• Product Code: DXG
• UDI-Device Identifier: 00690103194746
• UDI-Public: 00690103194746
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K131588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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
• Operator of Device: Health Professional
• Device Model Number: MHD6AZ5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown