MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET; VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM

Model Number PXVJ050M

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/03/2021

Event Type  malfunction  

Event Description

As reported, during use with patient of a disposable pressure transducer with vamp junior, the pressure tubing suddenly came away, resulting in patient bleeding into the bed (medwatch #09719).It is unknown how much blood leaked.Two new transducers were tried as replacement and the same issue occurred, although there was no blood loss at that time (medwatch #09785 and medwatch #09787).There were no complications or additional interventions needed.There was no allegation of patient injury.Patient demographics unable to be obtained.The product is expected to be returned for analysis; however, it has not yet been received.

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.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.

Manufacturer Narrative

One pressure monitoring set with vamp jr was received by our product evaluation laboratory for full examination.Customer report of tubing issue was confirmed.However, the pressure tubing was found completely broken from the proximal bond joint with vamp jr reservoir instead of being detached.Cross surfaces of broken tubing appeared rough and uneven.Broken mating tubing was visible at vamp jr reservoir bond joint.Residual adhesive visible on the broken tubing.Pressure tubing was found partially broken from the distal bond joint with vamp jr reservoir.Pressure tubing was found completely broken from the bond joint with male connector.Cross surfaces of broken tubing appeared rough and uneven.Broken mating tubing was visible at connector bond joint.Residual adhesive was visible on the broken tubing.No other visible damage was observed from returned kit.An engineering investigation has been initiated to consider any potential factors that may have contributed to this complaint.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.

Manufacturer Narrative

Based on further engineering investigation, it could be concluded that the type of fracture found indicates that plasticizer of the tubing material migrated to the surface causing the tubing fracture.Potential causes could be related to environment, time (tubing ageing), solvent (chemical reaction with tubing), tubing material and contact of the tubing with chemical agents.Pra was generated for this condition and edwards is initiating actions to further investigate the failure mode to eliminate the root cause(s) and to prevent recurrence of this type of complaint.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.

• Brand Name: PRESSURE MONITORING SET
• Type of Device: VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM
• Manufacturer (Section D): 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: 12867417
• MDR Text Key: 283092659
• Report Number: 2015691-2021-06496
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PXVJ050M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1