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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 PUMP MODULE SMARTSITE INFUSION SET; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS PUMP MODULE SMARTSITE INFUSION SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2420-0007
Device Problems Material Rupture (1546); Material Too Soft/Flexible (4007)
Patient Problem Burning Sensation (2146)
Event Date 02/11/2022
Event Type  malfunction  
Event Description
It was reported that the bd alaris pump module smartsite infusion set experienced tubing expansion.The following information was provided by the initial reporter: while nurse was priming tubing she noted the flexible portion of tubing was ballooning out and it ¿exploded¿ medication into nurses¿ face and eyes.Mds report pulled by pharmacist and nurse rinsed eyes at eye wash station and washed face and lips with soap and water.
 
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 pump module smartsite infusion set experienced tubing expansion.The following information was provided by the initial reporter: while nurse was priming tubing she noted the flexible portion of tubing was ballooning out and it ¿exploded¿ medication into nurses¿ face and eyes.Mds report pulled by pharmacist and nurse rinsed eyes at eye wash station and washed face and lips with soap and water.
 
Manufacturer Narrative
H.6.Investigation: one sample (model #2420-0007) was returned by the customer.It was reported that the tubing was ballooning out and it exploded.The set was examined for defects and abnormalities.The sample arrived separated at the top connection of the pumping segment.A retainer ring indent was visible, though no retainer ring was returned.A definitive root cause could not be determined since an infusion could not be completed with the returned sample.The separation could have possibly been a result of the excessive force from the ballooning reported in the pumping segment.We will continue to track this issue and watch for any emerging trends.A potential lot number was identified to be lot #21106126.A device history record review for model 2420-0007 and possible lot number 21106126 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
 
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Brand Name
BD ALARIS PUMP MODULE SMARTSITE INFUSION 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 Key13669614
MDR Text Key287024419
Report Number9616066-2022-00200
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203021012
UDI-Public07613203021012
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
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 03/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2420-0007
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? Yes
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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