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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¿ LOW SORBING INFUSION SET; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING INFUSION SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 11532269
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/02/2023
Event Type  malfunction  
Event Description
It was reported that an unspecified number of bd alaris¿ pump module smartsite¿ low sorbing infusion sets were received damaged.The following information was provided by the initial reporter: "they were received damaged".
 
Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
Correction: b5: describe event or problem: it was reported that an unspecified number of bd alaris¿ pump module smartsite¿ low sorbing infusion sets were received with the unit open and the sterility of the product is compromised.The following information was provided by the initial reporter: "they were received damaged".
 
Event Description
It was reported that an unspecified number of bd alaris¿ pump module smartsite¿ low sorbing infusion sets were received with the unit open and the sterility of the product is compromised.The following information was provided by the initial reporter: "they were received damaged".
 
Event Description
It was reported that an unspecified number of bd alaris¿ pump module smartsite¿ low sorbing infusion sets were received with the unit open and the sterility of the product is compromised.The following information was provided by the initial reporter: "they were received damaged".
 
Manufacturer Narrative
H6: investigation summary: one photo was received for quality investigation.The customer complaint of package damage was confirmed by review of the photo submitted by the customer.The photo received shows that the product packaging was damaged on the side of the packaging, opening a large hole in the box.A device history record review for model 11532269 lot number 23025004 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause for the failure could not be fully determined because the damaged product was not received.The probable cause of the damage is that the damage occurred during the shipping of the product.
 
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Brand Name
BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING 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 Key17000978
MDR Text Key315908589
Report Number9616066-2023-01015
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403232343
UDI-Public10885403232343
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,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/15/2023
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 Other
Device Catalogue Number11532269
Device Lot Number23025004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/02/2023
Initial Date FDA Received05/25/2023
Supplement Dates Manufacturer Received06/01/2023
06/15/2023
Supplement Dates FDA Received06/09/2023
06/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2023
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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