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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 2420-0500
Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/18/2023
Event Type  malfunction  
Event Description
It was reported that the bd alaris¿ pump module smartsite¿ infusion set tubing had a pinhole in it that leaked out saline during use.The following information was provided by the initial reporter: "i walked into a room where an infusion pump was alarming, air-in-line, and was attempting to resolve the issue.I disconnected the tubing from the patient to allow me to run ns through and purge any air.(the bedside rn had just primed the tubing 5 minutes before and left the room to gather other supplies.) just as i was about to re-insert the tubing into the pump i noted fluid dripping.I found a pin-hole in the tubing near the upper blue fitment piece impact of incident: good catch - no harm.Who was affected? patient.Unexpected or prolonged care? no.What was the medication/fluid in use at the time of the event? from the report it looks like normal saline.Was there an alaris pump and pump module in use at the time of the event? if so, what pump module model was in use (8100, 8110, 8120)? what type of procedure is being performed? iv infusion".
 
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: d10: device available for eval yes, d10: returned to manufacturer on: 15-may-2023.H6: investigation summary: the customer reported a hole in the pumping segment, and returned the used sample.The sample was found to have a pinhole at the lower fitment in the silicon, and the complaint is verified.The root cause for these is not related to the manufacturing process.The pinhole can be caused by improper loading techniques.Device history record review for model 2420-0500 lot number 23015147 was performed.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 tubing had a pinhole in it that leaked out saline during use.The following information was provided by the initial reporter: "i walked into a room where an infusion pump was alarming, air-in-line, and was attempting to resolve the issue.I disconnected the tubing from the patient to allow me to run ns through and purge any air.(the bedside rn had just primed the tubing 5 minutes before and left the room to gather other supplies.) just as i was about to re-insert the tubing into the pump i noted fluid dripping.I found a pin-hole in the tubing near the upper blue fitment piece impact of incident: good catch - no harm.Who was affected? patient.Unexpected or prolonged care? no.What was the medication/fluid in use at the time of the event? from the report it looks like normal saline.Was there an alaris pump and pump module in use at the time of the event? if so, what pump module model was in use (8100, 8110, 8120)? what type of procedure is being performed? iv infusion".
 
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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
8448235433
MDR Report Key16916412
MDR Text Key315085924
Report Number9616066-2023-00874
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203012430
UDI-Public07613203012430
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 07/31/2023
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 Health Professional
Device Catalogue Number2420-0500
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/20/2023
Initial Date FDA Received05/11/2023
Supplement Dates Manufacturer Received07/31/2023
Supplement Dates FDA Received08/16/2023
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
BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET.
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