Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Excess Flow or Over-Infusion (1311); Defective Component (2292); Free or Unrestricted Flow (2945)
Patient Problems Abdominal Pain (1685); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2022
Event Type  malfunction  
Event Description
It was reported that the unspecified bd infusion set experienced flow issue.The following information was provided by the initial reporter: potential over-infusion or failed back check valve.Both primary and secondary bags rapidly infusing, and both bags emptied quicker than expected.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed in sections and the (b)(4) fda registration number has been used for the manufacture report number.
 
Event Description
It was reported that the unspecified bd infusion set experienced flow issue.The following information was provided by the initial reporter: potential over-infusion or failed back check valve.Both primary and secondary bags rapidly infusing, and both bags emptied quicker than expected.
 
Manufacturer Narrative
H.6.Investigation summary: four photos were returned by the customer.It was reported that they had potential over-infusion or failed back check valve, both primary and secondary bags rapidly infusing, and both bags emptied quicker than expected.The photos show the set-up, and also the underside of the back check valve appearing to have an air bubble.The customer clarified that this is a hole in the back check valve.The customer also stated that the plastic that composes the back check valve has inconsistencies.We are unable to determine if it is a manufacturing defect with the pictures that were provided.A quality notification was sent to the supplier, and the returned pictures were forwarded to the supplier for further investigation.The supplier was able to observe the returned pictures.The pictures show the system set up, and a close view of the check valve.The picture of the system set up does not show the smart site or the pump.Additional information was requested from bd, but since they did not have a physical sample, no more information could be provided.The pictures showing the check valve do not show any evidence of common check valve issues.The supplier is not able to conduct a full investigation at this time from the information given.A definitive root cause cannot be determined from the information given.Common issues seen on check valves include backflow and cracking pressure, which would result in a reduced or stopped flow.No further actions will be take at this time due to no physical sample or lot number being provided.Although true root cause was unable to be determined, the supplier continues to implement 100% in-line backflow verification during the assembly process.
 
Manufacturer Narrative
The following information has been corrected: b.5 describe event or problem: it was reported that the bd alaris¿ pump module smartsite¿ infusion set experienced flow issues, and component damage.The following information was provided by the initial reporter: potential over-infusion or failed back check valve.Both primary and secondary bags rapidly infusing, and both bags emptied quicker than expected.D.11 concomitant med prod desc: matl# 11448964, secondary set.H.6 investigation summary: four photos were returned by the customer.It was reported that they had potential over-infusion or failed back check valve, both primary and secondary bags rapidly infusing, and both bags emptied quicker than expected.The photos show the set-up, and also the underside of the back check valve appearing to have an air bubble.The customer clarified that this is a hole in the back check valve.The customer also stated that the plastic that composes the back check valve has inconsistencies.However, we are unable to determine if it is a manufacturing defect with the pictures that were provided.A quality notification was sent to the supplier, and the returned pictures were forwarded to the supplier for further investigation.The supplier was able to observe the returned pictures.The pictures show the system set up, and a close view of the check valve.The picture of the system set up does not show the smart site or the pump.Additional information was requested from bd, but since they did not have a physical sample, no more information could be provided.The pictures showing the check valve do not show any evidence of common check valve issues.The supplier is not able to conduct a full investigation at this time from the information given.A definitive root cause cannot be determined from the information given.Common issues seen on check valves include backflow and cracking pressure, which would result in a reduced or stopped flow.No further actions will be take at this time due to no physical sample or lot number being provided.Although true root cause was unable to be determined, the supplier continues to implement 100% in-line backflow verification during the assembly process.A device history record review could not be performed on model 2420-0007 because a lot number is unknown.A device history record review could not be performed on model 11448964 because a lot number is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
 
Event Description
It was reported that the bd alaris¿ pump module smartsite¿ infusion set experienced flow issues, and component damage.The following information was provided by the initial reporter: potential over-infusion or failed back check valve.Both primary and secondary bags rapidly infusing, and both bags emptied quicker than expected.
 
Manufacturer Narrative
Additional information was added by the customer.The following fields have been updated: b.5.Describe event or problem: it was reported that the bd alaris¿ pump module smartsite¿ infusion set experienced flow issues.D.1.Medical device brand name: bd alaris¿ pump module smartsite¿ infusion set.D.2.Medical device catalog#: 2420-0007.D.3.Medical device manufacturer: sistemas medicos alaris, s.A.De c.V.D.5.Unique identifier (udi) #: (b)(4).G.2.Manufacturing location: sistemas medicos alaris, s.A.De c.V.G.5.Pma / 510(k)#: k944320.H.6.Imdrf annex e grid: e1002.H.6.Imdrf annex f grid: f23.H.6.Imdrf annex a grid: a140502.
 
Event Description
It was reported that the bd alaris¿ pump module smartsite¿ infusion set experienced flow issues.The following information was provided by the initial reporter: potential over-infusion or failed back check valve.Both primary and secondary bags rapidly infusing, and both bags emptied quicker than expected.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 NJ 22244
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana NJ 22244
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14651825
MDR Text Key297041159
Report Number2243072-2022-00792
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203021012
UDI-Public(01)07613203021012
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,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 10/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2022
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/19/2022
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
Treatment
MATL# 11448964, SECONDARY SET
-
-