MAUDE Adverse Event Report: EDWARD LIFESCIENCES LLC TRUWAVE (3CC) VAMP 68 INCH PRESSURE MONITORING; TRANSDUCER, PRESSURE, CATHETER TIP

Device Problems Break (1069); Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2019

Event Type  Injury  

Event Description

Product malfunction.Edward lifesciences pressure monitoring set truwave (3cc) vamp 68 inch.While attempting to flush the blood back into the pt after a blood draw, the tubing from the vamp broke off from the vamp site causing blood to splash out and blood to back flow onto the floor.The white stopcock was turned off in front of the vamp to prevent any further blood loss.The pt was critical and now needed new tubing primed and change.No complication occurred to the pt.Product was saved for investigation.Fda safety report id# (b)(4).

• Brand Name: TRUWAVE (3CC) VAMP 68 INCH PRESSURE MONITORING
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARD LIFESCIENCES LLC; irvine CA 92612
• MDR Report Key: 8731022
• MDR Text Key: 149240707
• Report Number: MW5087584
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/20/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR