MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC TRUWAVE, VAMP JR.; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number VMP306PX

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

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2018

Event Type  malfunction  

Event Description

Vamp jr arterial line tubing broke apart when being set up prior to placement on infant.While priming the vamp jr with 0.9%ns, a segment of the vamp jr.Disconnected with rn's normal handling of the product.There was no tension placed; rather, when the product was in hand, the distal portion simply snapped off.This product was not connected to the patient during its priming.Iv product removed from service and kept with packaging.New product primed and then placed on baby.Product broke in flexible tubing, it did not separate at a hub or glued spot.

• Brand Name: TRUWAVE, VAMP JR.
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 7800570
• MDR Text Key: 117701801
• Report Number: 7800570
• 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: 07/24/2018

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: VMP306PX
• Device Catalogue Number: VMP306PX
• Device Lot Number: 61161578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 DA