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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. PCA 1 Y-SS CONN SET; CONNECTION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C. PCA 1 Y-SS CONN SET; CONNECTION SET Back to Search Results
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.
 
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Brand Name
PCA 1 Y-SS CONN SET
Type of Device
CONNECTION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.
blvd. insurgentes 20351
tijuana, null 22244
MX  22244
MDR Report Key10262794
MDR Text Key198506652
Report Number9616066-2020-02087
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 06/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number30842E-0006
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
20200619; 20200619; 20200619
Patient Outcome(s) Other;
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