MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC TRUWAVE (30ML) VAMP JR, PRESSURE MONITOR SET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number VMP306PX

Device Problems Break (1069); Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2021

Event Type  malfunction  

Event Description

Patient had a uac (umbilical arterial line) placed, with fluids infusing as ordered, uac line was connected to a truwave (30ml) vamp jr, pressure monitor set.(lot number is unknown, the expiration date is unknown, since packaging was not saved.) two days later, the line was found disconnected in the baby's bed, with blood from baby starting to back up into the tubing.Luckily this was caught very early before any patient blood was leaking out of tubing.The rn quickly clamped the line tubing at the closest juncture to the breakage of the line, and was able to attach a 10 ml syringe of normal saline flush, sterile, and flushed the blood back to baby.Md was notified and new iv fluids were ordered, and a new tubing, plus vamp jr was attached to baby.Charge rn saved the broken pieces of vamp jr, placed into plastic bag, and saved.The breakage in the vamp jr iv line was in a spot that is normally permanently affixed.As in: this is not a spot in the line where other tubing is usually connected.It is not supposed to come apart.

• Brand Name: TRUWAVE (30ML) VAMP JR, PRESSURE MONITOR SET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 11699753
• MDR Text Key: 246566766
• Report Number: 11699753
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2021

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: No Information
• Device Model Number: VMP306PX
• Device Catalogue Number: VMP306PX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1