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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS PCA ADMINISTRATION KIT; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS PCA ADMINISTRATION KIT; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2477-0007
Device Problem Backflow (1064)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2022
Event Type  malfunction  
Event Description
It was reported that the bd alaris pca administration kit experienced check valve malfunction.The following information was provided by the initial reporter: the blood is going back into the saline bag even when the roller clamp is closed.
 
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 bd alaris pca administration kit experienced check valve malfunction.The following information was provided by the initial reporter: the blood is going back into the saline bag even when the roller clamp is closed.
 
Manufacturer Narrative
H.6.Investigation: one photo was taken by the customer.The photo can't verify the customer complaint that the blood is going back into the saline bag even when the roller clamp is closed.No product was returned by the customer.The customer complaint that the blood is going back into the saline bag even when the roller clamp is closed could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
 
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Brand Name
BD ALARIS PCA ADMINISTRATION KIT
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13876503
MDR Text Key287806577
Report Number9616066-2022-00317
Device Sequence Number1
Product Code FPA
UDI-Device Identifier37613203019478
UDI-Public37613203019478
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K894842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2477-0007
Device Catalogue Number2477-0007
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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