Catalog Number 30842E-0006 |
Device Problems
Complete Blockage (1094); Restricted Flow rate (1248)
|
Patient Problem
Underdose (2542)
|
Event Date 06/19/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
|
|
Event Description
|
It was reported that the pca 1 y-ss conn set was clogged/blocked/occluded.The product defect resulted in a serious injury with the customer not receiving their bolus dosage.The following information was provided by the initial reporter: unable to give rapid bolus during resus dr.Reported unable to give patient a rapid bolus during resus.The connector was checked and able to give slower infusions (via pump) and flushes, however dr.Reported the set felt ¿blocked¿ when giving rapid iv push.
|
|
Manufacturer Narrative
|
A 30842e-0006 sample was not available for investigation of this feedback; however the customer indicates that a flow restriction was experienced during attempts to give a bolus through the extension set.No further information was available to assist the investigation.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined in this instance.Without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported issue.A review of the customer feedback database indicates that this is an isolated occurrence with no other similar report against the 30842e-0006 set in the past 12 months.
|
|
Event Description
|
It was reported that the pca 1 y-ss conn set was clogged/blocked/occluded.The product defect resulted in a serious injury with the customer not receiving their bolus dosage.The following information was provided by the initial reporter: unable to give rapid bolus during resus dr.Reported unable to give patient a rapid bolus during resus.The connector was checked and able to give slower infusions (via pump) and flushes, however dr.Reported the set felt ¿blocked¿ when giving rapid iv push.
|
|
Search Alerts/Recalls
|