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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
Model Number 2420-0007
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter zip: v5z 1m9.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd alaris pump module smartsite infusion set was involved with a case of overinfusion.The following information was provided by the initial reporter: the customer reported a suspected over-infusion or back check valve failure under.
 
Manufacturer Narrative
Initial reporter zip: v5z 1m9.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd alaris pump module smartsite infusion set was involved with a case of overinfusion.The following information was provided by the initial reporter: the customer reported a suspected over-infusion or back check valve failure under.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-mar-16.Potential lot numbers were identified for the returned sets: d4: medical device lot #: 21115845.D4: medical device expiration date: 2024-nov 13.H4: device manufacture date: date: 2021-nov 13.D4: medical device lot #: 21115911.D4: medical device expiration date: 2024-nov 14.H4: device manufacture date: 2021-nov 14.D4: medical device lot #: 21115891.D4: medical device expiration date: 2024-nov 13.H4: device manufacture date: 2021-nov 13.D4: medical device lot #: 21115842.D4: medical device expiration date: 2024-nov 13.H4: device manufacture date: 2021-nov 13.D4: medical device lot #: 21115922.D4: medical device expiration date: 2024-nov 16.H4: device manufacture date: 2021-nov 16.H6: investigation summary: one primary tubing (model 2420-0007) and one secondary tubing were returned by the customer.It was reported that there was an over infusion with the tubing set.The samples were examined for defects and abnormalities.No defects or abnormalities were observed.Functional testing was performed by using a primary bag filled with clear saline which was then used to prime the set.The secondary set was connected to a bag filled with a blue dye/water mixture, and then connected to the primary set.The sets were set up in a secondary infusion configuration with the fluid level of the secondary bag at least 9.5 inches higher than the primary bag fluid level, and all of the clamps closed.The secondary set was primed with the secondary roller clamp fully opened.Fluid flow was controlled using the primary roller clamp.Fluid was found to be flowing normally.No back flow was observed.An infusion was completed using the bd alaris pump (dchu-0010) and pump module (dchu-0013) at 125 ml/hr with a vtbi of 125 ml.Fluid was flowed into an empty beaker.After 1 hour there was about 125 m/l of saline in the beaker.Fluid was flowing normally.No back flow was observed.The failure was unable to be replicated, and the complaint could not be verified.A root cause was unable to be determined because the failure was unable to be replicated.Multiple potential lot numbers were identified for the returned sets: 21115845, 21115911, 21115891, 21115842, 21115922.A device history record review for model 2420-0007 and potential lot number 21115845 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 15nov2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 and potential lot number 21115911 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 17nov2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 and potential lot number 21115891 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 16nov2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 and potential lot number 21115842 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 18nov2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 and potential lot number 21115922 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 17nov2021.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 pump module smartsite infusion set was involved with a case of overinfusion.The following information was provided by the initial reporter: the customer reported a suspected over-infusion or back check valve failure under.
 
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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 Key13563338
MDR Text Key286019873
Report Number9616066-2022-00159
Device Sequence Number1
Product Code FPA
UDI-Device Identifier37613203021020
UDI-Public37613203021020
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/09/2022
Initial Date FDA Received02/18/2022
Supplement Dates Manufacturer Received03/18/2022
Supplement Dates FDA Received04/06/2022
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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