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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¿ SMARTSITE¿ LOW SORBING EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ SMARTSITE¿ LOW SORBING EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number G30454V
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2021
Event Type  malfunction  
Event Description
It was reported that the bd alaris¿ smartsite¿ low sorbing extension set was leaking chemotherapy drugs at the iv tubing connection site.There was no patient impact.The following information was provided by the initial reporter: "using the alaris 9002tig01-g infusion pump with the low sorbing (tpe) extension set with the clamps for oncology, there has been leaks coming from the junction of the tubing at the connector at the very end where the set connects with an iv line.It is leaking chemotherapy drugs!".
 
Manufacturer Narrative
Medical 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.
 
Manufacturer Narrative
Correction: after further evaluation of the complaint, it has been determined that the previously submitted mfr report# 9616066-2021-52660 was sent in error.This device is manufactured in a facility that does not manufacture devices for the us market.These devices are sold outside of the us and are not similar to bd devices registered or sold in the us.Therefore, this is exempt from from us fda reporting requirements.H3 other text : see h10.
 
Event Description
It was reported that the bd alaris¿ smartsite¿ low sorbing extension set was leaking chemotherapy drugs at the iv tubing connection site.There was no patient impact.The following information was provided by the initial reporter: "using the alaris 9002tig01-g infusion pump with the low sorbing (tpe) extension set with the clamps for oncology, there has been leaks coming from the junction of the tubing at the connector at the very end where the set connects with an iv line.It is leaking chemotherapy drugs!".
 
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Brand Name
BD ALARIS¿ SMARTSITE¿ LOW SORBING EXTENSION 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 Key13120279
MDR Text Key285616782
Report Number9616066-2021-52660
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/28/2022
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 Health Professional
Device Catalogue NumberG30454V
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/04/2021
Initial Date FDA Received12/30/2021
Supplement Dates Manufacturer Received01/28/2022
Supplement Dates FDA Received02/11/2022
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
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