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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 LOW SORB 2SS 0.2M CV; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D LOW SORB 2SS 0.2M CV; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 11532269
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the as lvp 20d low sorb 2ss 0.2m cv tubing broke while hanging reflexis.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "we had the bd alaris pump infusion set tubing break on the nurse when she was hanging reflexis.".
 
Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.The customer complaint of alaris tubing broke could not be verified due to the product not being returned for failure investigation.A device history record review for model 11532269 lot number 20065136 was performed.The search showed that a total of 7,683 units in 1 lot number was built on 01jun2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.H3 other text : see h.10.
 
Event Description
It was reported that the as lvp 20d low sorb 2ss 0.2m cv tubing broke while hanging reflexis.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "we had the bd alaris pump infusion set tubing break on the nurse when she was hanging reflexis.".
 
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Brand Name
AS LVP 20D LOW SORB 2SS 0.2M CV
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 22244
MX  22244
MDR Report Key11087149
MDR Text Key245042208
Report Number9616066-2020-20659
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50885403232341
UDI-Public50885403232341
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 01/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/01/2023
Device Model Number11532269
Device Catalogue Number11532269
Device Lot Number20065136
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2020
Date Manufacturer Received01/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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