EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP JR.; TRANSDUCER, PRESSURE, CATHETER TIP
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Model Number VJ0095 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Date 02/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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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).
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Event Description
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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.The clinician pulled on the vamp jr.Reservoir in order to obtain a clearing volume and air was noted in the line.The radial artery line was discontinued and there was a clot in the end of the catheter.In addition, an occlusive radial artery clot was observed.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 the current status of the patient or patient demographics.
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