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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 SMARTSITE LOW SORBING SET; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE LOW SORBING SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 10013902
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Arrest (1762)
Event Date 05/18/2022
Event Type  Injury  
Event Description
It was reported that the bd alaris smartsite low sorbing set required a larger amount of priming leading to the patient receiving unspecified medical intervention under a "code blue." the following information was provided by the initial reporter: they have reported that they had a code blue due to the larger priming volume of the sub.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9 device available for eval: yes.D.9 returned to manufacturer on: 07-jun-2022.H.6 investigation summary: 25 unused sample model 10013902 were returned for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were primed with normal saline.No issues of leakage were observed.The customer complaint that the sets were leaking could not be replicated.The root cause could not be determined because the issue could not be replicated.There is a difference in priming volumes of the original set model 10010570 and the substitute set model 10013902.In this instance there is no issue with model 10013902 because the set is working as intended.10010570 has a prime volume of ~1 ml.10013902 has a prime volume ~4ml.A device history record review for model 10013902 lot number 22039224 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
 
Event Description
It was reported that the bd alaris smartsite low sorbing set required a larger amount of priming leading to the patient receiving unspecified medical intervention under a "code blue." the following information was provided by the initial reporter: they have reported that they had a code blue due to the larger priming volume of the sub.
 
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Brand Name
BD ALARIS SMARTSITE LOW SORBING SET
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 Key14715127
MDR Text Key294573302
Report Number9616066-2022-00715
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50885403233812
UDI-Public50885403233812
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960280
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 06/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number10013902
Device Catalogue Number10013902
Device Lot Number22039224
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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