MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP JR.; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number VJ0095

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 02/14/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.However, two representative used samples from the nicu were returned for evaluation.Both samples were determined to be ¿no fault found¿.The dhrs of these samples showed that a review of the manufacturing records indicated that the products met specifications upon release.An edwards representative visited the facility to review and ensure proper usage of the product per the ifu instructions.There are several statements in the ifu to assist the clinician in the use of the vamp jr.¿recommended rate to pull the reservoir plunger up to the fully open position is approximately 1ml every 10-15 seconds.¿ in order to avoid excessive negative pressure from being generated, it is important that the instructions outlined in the ifu for withdrawal rate be followed.¿if difficulties are experienced or bubbles are observed when drawing the clearing volume, check catheter and kit for possible loose connections, occlusions or restrictions (e.G.Positional lines).¿ it is unknown whether user or procedural factors played a role in the stated event.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 a part of the monthly review.(b)(4).

Event Description

It was reported that 24-48 hours into use of a vamp jr.Blood sampling system with an icu medical disposable pressure transducer (dpt), perfusion changes were observed in the extremity of an infant of unknown age in the nicu.The dpt was on a pump.Upon removal of the arterial line, clots were found on the end of the catheter.It was believed by the clinician that the diminished perfusion was related to air entrapment in the arterial line following an attempted blood draw.This unit was discarded at the facility but 2 used representative samples were sent for evaluation.Despite repeated attempts, no further information has been obtained regarding treatment at the time of the event, current status of the patient or patient demographics.

• Brand Name: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP JR.
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 7329204
• MDR Text Key: 102067039
• Report Number: 2015691-2018-00831
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2018
• Device Model Number: VJ0095
• Device Lot Number: 61177742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2017
• 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
• Patient Outcome(s): Required Intervention