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

Model Number	MHD6C502
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes include: dqe- catheter, oximeter, fiberoptic.Drs- transducer, blood-pressure, extravascular.The device evaluations is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the results become available.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 process.
Event or Problem Description
As reported, when the flotrac was removed from the packaging, the tubing came off the stopcock with minimal manipulation.No troubleshooting was attempted as the tubing came apart during set up.There was no allegation of patient injury.The device is available for return.
Additional Manufacturer Narrative
One flotrac - dpt - vamp adult combo kit was returned for product evaluation.The customer report of tubing came off was confirmed.The tube adapter of iv male connector, which was connected to flotrac unit, was completely broken.The broken part of the adapter remained inside of iv tube.Cross surfaces of broken adaptor appeared uneven and rough.Lab findings were not consistent with customer photos.Customer photos showed damage on pressure tubing set while returned kit had damage on iv set.No other visible damage was observed from the returned kit.Based on product evaluation findings this event is no longer considered reportable.Therefore, this correction is being submitted.

• Brand Name: FLOTRAC, VAMP, TRUWAVE
• 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 IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 21447006
• Report Number: 2015691-2025-01269
• Device Sequence Number: 7724371
• Product Code: DXG
• UDI-Device Identifier: 00690103194760
• UDI-Public: (01)00690103194760(17)260715(11)240715(10)65920855
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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 Expiration Date: 07/15/2026
• Device Model Number: MHD6C502
• Device Lot Number: 65920855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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