MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, DR FLOTRAC; CATHETER, OXIMETER, FIBEROPTIC

Model Number	MHD6S
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested to be returned but has not yet arrived for evaluation.The device history record review was not completed as the lot number is unknown.Once the product evaluation has been completed a supplemental submission will be sent with the findings.
Event or Problem Description
It was reported that there were inaccurate arterial blood pressure values with the pressure monitoring flotrac sensor.This occurred during patient monitoring.The blood pressure values on the patient bedside monitor were 5 to 10mmhg higher than what was being displayed on the hemosphere monitor.There were no error messages that displayed.There was no abnormal waveform that displayed.There was no troubleshooting or replacement of the device that was performed.The pressure monitoring device was able to be zeroed before use.There was no occlusion, leakage or kink that occurred.The information regarding the expected values and whether the values and the waveform matched are not known.The patient demographics were requested but are unavailable.There was no inappropriate treatment administered to the patient.The other edwards components used in the monitoring were ruled out as suspect.There is no patient harm or injury.
Additional Manufacturer Narrative
The product was returned for evaluation.The product evaluation found that the reported issue was not confirmed.There was no visible damage or abnormality observed from the entire unit.There were no error messages observed on the hemosphere monitor and pressure monitor when the suspect flotrac unit was connected.The flotrac device zeroed and sensed pressure accurately on the hemosphere unit and the pressure monitor, respectively.Pressure did not show any drift during the output drift testing.Initial pressure 150 mmhg, final pressure 150 mmhg for the flotrac sensor.The device met specifications per drawings.The electrical testing showed that both input impedance and output impedance were within specifications.There was no defect found.No escalation is required.This supplemental mdr is being submitted due to product evaluation findings.Sections g6, h2, h6: type of investigation, investigation findings, and investigation conclusions have been updated.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.
Additional Manufacturer Narrative
Udi related data quality updates only the following are additional product codes for this device drs transducer, blood pressure, extravascular dxg computer, diagnostic, pre programmed, single function the lot number for this device was not provided and is unknown, therefore, the full udi number is not available.The primary di number is (b)(4).The following is corrected data, as the original identification information sent did not match the data submitted to the global unique device identification database (gudid) d1 brand name: flotrac.D2a common device name catheter, oximeter, fiberoptic.D2b device product code dqe.

• Brand Name: FLOTRAC
• Common Device Name: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; one edwards way; irvine, CA 92614
• MDR Report Key: 18366650
• Report Number: 2015691-2023-18607
• Device Sequence Number: 7771385
• Product Code: DQE
• UDI-Device Identifier: 00690103194586
• UDI-Public: (01)00690103194586
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2024
• 2 Devices were Involved in the Event: 1 2

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: MHD6S
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 01/25/2024; 07/09/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/15/2024; 07/18/2024
• 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