MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR FLOTRAC; COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Model Number	MHD65
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Device was discarded.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.Further evaluation regarding related quality issues is under investigation.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 that while a nurse was repositioning a patient it was noticed that the flotrac arterial tubing came apart at the connection below the transducer.No harm to patient.It was caught immediately.It was reported that the defective sample was discarded by clinician.Per the customer, the connection that came apart was a non bonded connection.
Additional Manufacturer Narrative
Although image was provided for this complaint reported as flotrac system - broken, separated after image evaluation performed the defect could not be confirmed.Reviews of the device history record, lot history and manufacturing mitigations revealed no indication that a manufacturing non-conformance contributed to the reported complaint.As such, based on available information, a definite root cause is unable to be determined at this time.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.
Additional Manufacturer Narrative
Udi related data quality updates only.The following are additional product codes for this device: drs transducer, blood-pressure, extravascular.Dqe catheter, oximeter, fiberoptic.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: computer, diagnostic, pre-programmed, single-function.D2b device product code: dxg.

• Brand Name: FLOTRAC
• Common Device Name: COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 17985734
• Report Number: 2015691-2023-16984
• Device Sequence Number: 7420013
• Product Code: DXG
• UDI-Device Identifier: 00690103194593
• UDI-Public: (01)00690103194593(17)240807(11)220808(10)64545511
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• 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
• Device Expiration Date: 08/07/2024
• Device Model Number: MHD65
• Device Lot Number: 64545511
• Was Device Available for Evaluation?: No
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 12/13/2023; 07/10/2024
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 12/14/2023; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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