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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT SET .2 MF LOW SORB; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT SET .2 MF LOW SORB; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 10013902
Device Problem Complete Blockage (1094)
Patient Problems Underdose (2542); Insufficient Information (4580)
Event Date 12/02/2020
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 ext set.2 mf low sorb had flow issues while infusing taxol, leaving "140 cc" left in the bag.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "this was an under infusion incident- once chemo (taxol) infusion was completed there was still 140 cc left over of chemo in the bag.(total volume 608cc)".
 
Event Description
It was reported that the ext set.2 mf low sorb had flow issues while infusing taxol, leaving "140 cc" left in the bag.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "this was an under infusion incident- once chemo (taxol) infusion was completed there was still 140 cc left over of chemo in the bag.(total volume 608cc).".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 1/14/2021.H6: investigation: it was reported that 140 cc of chemo was left over in the bag.A device history record review for model 10013902 lot number 20086307 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The sample(s) were inadvertently misplaced during the chemo decontamination process, but if found, a full investigation will be completed.However, the root cause of this failure was not identified as no product was received to undergo investigation.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues: accuracy with lot #20086307 regarding item #10013902.
 
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Brand Name
EXT SET .2 MF LOW SORB
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 Key11131916
MDR Text Key225558800
Report Number9616066-2020-20733
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50885403233812
UDI-Public50885403233812
Combination Product (y/n)N
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/12/2023
Device Model Number10013902
Device Catalogue Number10013902
Device Lot Number20086307
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2021
Date Manufacturer Received03/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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