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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2021

Event Type  malfunction  

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.

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

One pressure monitoring set with vamp jr was received by our product evaluation laboratory for a full examination.The report of tubing issue was confirmed.However, pressure tubing was found completely broken from the distal 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 reservoir bond.Residual adhesive visible on the broken tubing.No other visible damage was observed from returned kit.Tubing breakage is a unique issue that has been investigated and the root cause is a combination of excess solvent and stress on a portion of the tubing in the package.If tubing breakage occurs during use, it would most likely be identified by a small amount of fluid or blood loss.With this device there was no blood loss.The system can be exchanged with a minimal delay in treatment or monitoring.As such, this event is no longer considered reportable and a corrected supplemental report is being submitted.

• 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: 12867410
• MDR Text Key: 283092895
• Report Number: 2015691-2021-06494
• 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
• Report Date: 12/16/2021

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
• Device Operator: Health Professional
• Device Model Number: PXVJ050M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/16/2021
• 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