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

Model Number	PXVJ050M
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)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use in patient with this disposable pressure transducer with vamp jr, the pressure tubing became disconnected right beside the sampling syringe.Whilst taking a sample of blood from the patient the nurse noticed a small patch of blood on the sheets which she found to be as a result of the bonded tube connection breaking off.The line was immediately clamped, and the arterial line pressure transducer kit was changed.There was no allegation of patient injury.The device was available for evaluation.
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.
Additional Manufacturer Narrative
Updated: b5 (describe event or problem), h3 (device evaluated by manufacturer), h6 (device code, investigation findings, investigation conclusions).The disposable pressure transducer with vamp jr involved in this complaint was not received for evaluation.Since the affected unit was not returned for evaluation, a product non-conformance or device failure could not be confirmed.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met, and inspections passed successfully.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.
Event or Problem Description
As reported, during use in patient with this disposable pressure transducer with vamp jr, the pressure tubing became disconnected right beside the sampling syringe.Whilst taking a sample of blood from the patient the nurse noticed a small patch of blood on the sheets which she found to be as a result of the bonded tube connection breaking off.The line was immediately clamped, and the arterial line pressure transducer kit was changed.There was no allegation of patient injury.The device was not available for evaluation.

• Brand Name: VAMP PLUS 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: 19547053
• Report Number: 2015691-2024-04644
• Device Sequence Number: 17356345
• Product Code: KRA
• UDI-Device Identifier: 07460691960572
• UDI-Public: (01)07460691960572(17)250223(11)230224(10)64793347
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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: 02/23/2025
• Device Model Number: PXVJ050M
• Device Lot Number: 64793347
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 08/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2023
• 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