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

Model Number	T005048B
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product 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.
Event or Problem Description
As reported, during use in patient of this disposable pressure transducer with vamp, the pressure tubing between the dpt housing and vamp detached from the vamp side.There was 3-5ml of blood loss.There was no allegation of patient injury.
Additional Manufacturer Narrative
One disposable pressure transducer with vamp was received by our product evaluation laboratory for a full examination.The report of pressure tubing detached was confirmed.As received, the pressure tubing had been completely detached from the bond joint with the vamp adult reservoir.Indication of bonding material was evident at the reservoir bond surface area.Mating parts of the pressure tubing were not returned.Also, the pressure tubing was found completely broken from the bond joint between pressure tubing and vamp adult reservoir stopcock.The pressure tubing was visible at the bond joint.Cross surfaces of broken tubing appeared rough and uneven.Based on further engineering evaluation, there are manufacturing controls to avoid potential causes related to the reported malfunction.However, no specific root cause could be established.Nevertheless, the manufacturing personnel has been notified in order to avoid the occurrence of similar events.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.All events will continue to be reviewed and monitored.

• Brand Name: VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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 ; 9492503939
• MDR Report Key: 20671367
• Report Number: 2015691-2024-08577
• Device Sequence Number: 17963459
• Product Code: KRA
• UDI-Device Identifier: 57460691949275
• UDI-Public: (01)57460691949275(17)250316(11)230317(10)64807987
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173586
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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: 03/16/2025
• Device Model Number: T005048B
• Device Lot Number: 64807987
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2023
• 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: Male