MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CO-SET PLUS FLOW-TRU HOUSING; PROBE, THERMODILUTION

Model Number	93505
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use in patient with this manifold, it broke during the mobilization procedure and a blood leakage was produced.To solve the issue the device was replaced.As per the hospital information the pharmaceutical service, confirmed that there was an evident leak through the thermistor cable was connected.The amount of blood lost by the patient was not measured.There was no allegation of patient injury.The device was not available for evaluation.It was discarded as the device was heavily impregnated with the patient's blood.
Additional Manufacturer Narrative
It was further informed that the device was not available for evaluation since it was discarded at hospital.However, an engineering evaluation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.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 part of this monthly review.
Additional Manufacturer Narrative
Corrected data: corrected section h3 - device evaluated by manufacturer updated section h6 (component code, device code, type of investigation, investigation findings, investigation conclusions) no product was returned for evaluation since it was discarded at the hospital.Based on further engineering investigation, there is no indication that a manufacturing nonconformance contributed to the reported complaint.There are manufacturing controls to avoid potential causes related to the reported malfunction.In addition, without the return of the product, a definite root cause is unable to be determined.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.

• Brand Name: CO-SET PLUS FLOW-TRU HOUSING
• Common Device Name: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haiana, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haiana, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 20320087
• Report Number: 2015691-2024-07437
• Device Sequence Number: 7782482
• Product Code: KRB
• UDI-Device Identifier: 07460691949973
• UDI-Public: (01)07460691949973(17)281210(11)231212(10)65298657
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K833997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: 93505
• Device Lot Number: 65298657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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