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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D DEHP 2SS CV INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D DEHP 2SS CV INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2420-0500
Device Problems Leak/Splash (1354); Stretched (1601)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2021
Event Type  malfunction  
Manufacturer Narrative
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 20123020. Medical device expiration date: 2023-12-15. Device manufacture date: 2020-11-27. Medical device lot #: unknown. Medical device expiration date: unknown. Device manufacture date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the as lvp 20d dehp 2ss cv tubing from lot 20123020 expanded while priming. Additionally, another tubing set from an unspecified lot broke apart during use. The following information was provided by the initial reporter: "event 1 it was reported that when priming the primary set, the rn noticed a bubble in the soft plastic of the tubing that gets inserted in the pump. Event 2: it was reported that a primary set broke where the soft plastic meets the hard blue plastic. " "when priming the primary set the rn noticed a bubble in the soft plastic of the tubing that gets inserted into the pump. This tubing was never placed in a pump. The rn noticed the default prior to placing in the pump. " "prior to this occurrence we had a primary set break where the soft plastic meets the hard blue plastic. We did not have a lot number on this malfunction. ".
 
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Brand NameAS LVP 20D DEHP 2SS CV
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 Key11532486
MDR Text Key265643466
Report Number9616066-2021-50521
Device Sequence Number1
Product Code FPA
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,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2420-0500
Device Catalogue Number2420-0500
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2021
Was Device Evaluated by Manufacturer? Yes
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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