MAUDE Adverse Event Report: VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM WITH ARM MOUNT RESERVOIR; ARTERIAL BLOOD SAMPLING KIT

Model Number	48VMP120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.The udi number for this device is: (b)(6).
Event or Problem Description
It was reported that while using this vamp after inserting an arterial line, the tubing separated from connector luer lock at the end closest to the patient.The patient was not a peds patient.It was a (b)(6) years old female with an acute stroke in the icu.There was minimal blood loss but no injury to the patient.
Additional Manufacturer Narrative
One pressure tubing with bonded sample site and male connector was returned for evaluation.Dry blood was visible inside pressure tubing and sample site.The reported event of tubing separation was confirmed.Received a pressure tubing with bonded sample site and male connector.Tubing end appeared smooth, even and tapered.Pressure tubing end had been most likely completely detached from bond joint with vamp adult reservoir stopcock.Tubing bended near the point of detachment.Indication of bonding material was visible on some locations of tubing bonding surface area.Tubing original diameter, 0.1420", measured near tubing bond area, was within specification.No other visible damage was observed from the kit.A device history record review was completed and documented that device met all specifications upon distribution.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.

• Brand Name: VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM WITH ARM MOUNT RESERVOIR
• Common Device Name: ARTERIAL BLOOD SAMPLING KIT
• MDR Report Key: 12239378
• Report Number: 2015691-2021-04380
• Device Sequence Number: 5402945
• Product Code: CBT
• UDI-Device Identifier: 07460691951792
• UDI-Public: (01)07460691951792(17)220825(11)200825(10)63347877;(01)57460691951797(17)220825(11)200825(10)63347877
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: CLASS I EXE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: No Information
• Device Expiration Date: 08/25/2022
• Device Model Number: 48VMP120
• Device Catalogue Number: 48VMP120
• Device Lot Number: 63347877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2020
• 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: 49 YR