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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. PCA ASV MICROBORE INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. PCA ASV MICROBORE INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 30883
Device Problems Stretched (1601); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/13/2021
Event Type  malfunction  
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.
 
Event Description
It was reported that the pca asv microbore tubing had ballooned near where it entered into the channel, and the pump was stopped with the remaining "28. 6ml" of "doxorubicin". This complaint was created to capture the 4th of 6 related incidents. The following information was provided by the initial reporter: "date reported: 2/25; extent of harm: reached the individual: ballooning of iv tubing product. Item: alaris pump iv module & bd alaris 3-port tubing: item and lot number: being investigated currently. Item currently being reviewed by clinical engineering alongside with the alaris channel. Doxorubicin medication pump continued to state that "patient side was occluded",no visible occlusion or bent tubing, once i opened the channel on pump, visible ballon on tubing that goes inside channel. Pump was stopped with 28. 6ml remaining of medication. ".
 
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Brand NamePCA ASV MICROBORE
Type of DeviceINTRAVASCULAR 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11571255
MDR Text Key265642304
Report Number9616066-2021-50566
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K811885
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
Report Date 04/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number30883
Device Catalogue Number30883
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Returned to Manufacturer03/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2021
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

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