MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VAMP PLUS VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	T001691M
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation; the device was infected with patient's blood.Nevertheless, images were provided for evaluation.Based on image review, the report was confirmed.The images showed a closeup on the lass valve ports.In one of the valves, the septum was noticed stuck down in open position.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.
Event or Problem Description
As reported, during use in patient with this disposable pressure transducer with vamp plus, when the user went to take a sample for laboratory tests, the distal sampling site was found completely collapsed and it was not possible to be returned to its initial position.The blood was leaking continuously.The device was changed for a new one and no additional intervention was needed to solve the issue.The device was not available for evaluation.
Additional Manufacturer Narrative
Further information received from the site confirmed that there was no allegation of patient injury.Based on investigation performed by engineers in the manufacturing site, it could be concluded that this failure can be caused by the incorrect insertion of the syringe during the process.The proper way per the recommended elcam method by inserting the tip and rotating the syringe about one quarter turn while seating.According to this information, there is no evidence related to manufacturing or supplier deficiencies that could cause the type of failure experienced by the costumer.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.The root cause of the collapsed valve is related to the insertion technique and the use of marginal compliant luer syringes.Edwards will continue to review and monitor all events.
Event or Problem Description
As reported, during use in patient with this disposable pressure transducer with vamp plus, when the user went to take a sample for laboratory tests, the distal sampling site (blue) was found completely collapsed and it was not possible to be returned to its initial position (see pictures attached).The blood was leaking continuously.The device was changed for a new one.There was no allegation of patient injury.No additional intervention was needed to solve the issue.The device was not available for evaluation; however, images were available.

• Brand Name: VAMP PLUS VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 19655921
• Report Number: 2015691-2024-05021
• Device Sequence Number: 6632459
• Product Code: KRA
• UDI-Device Identifier: 07460691959477
• UDI-Public: (01)07460691959477(17)260311(11)240311(10)65671418
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181684
• 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,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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 Expiration Date: 03/11/2026
• Device Model Number: T001691M
• Device Lot Number: 65671418
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• 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 Age: 60 YR
• Patient Sex: Female