• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT SET SMALLBORE .2MF PED INTRAVASCULAR ADMINISTRATION SET

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT SET SMALLBORE .2MF PED INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 10011865
Device Problem Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); Missed Dose (2561)
Event Date 09/28/2020
Event Type  malfunction  
Manufacturer Narrative
Date of birth: unknown. The patient¿s age was used to determine a placeholder date for this field. The initial reporter also notified the fda on 26 october, 2020. Medwatch report # (b)(4). Report source other: medwatch report. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that ext set smallbore. 2mf ped leaked. The following information was provided by the initial reporter: material #: 10011865; batch/ lot #: 20045504. It was reported that tpn was leaking from the flat circular part of the filter. Verbatim: s: i found that my patient's tpn was leaking from somewhere in the 0. 2 micron filter (ref# 10011865). B: on patient assessment, i felt a wet spot on the side rail of the crib around where the tpn tubing was laying. On inspection, it appeared that tpn was leaking from the flat circular part of the filter. I could see liquid appearing out of the filter, but could not see a cracks or breaks in the line or from the actual filter. I notified the medical team and we stopped the tpn infusion and i removed all the tubing and replaced it with maintenance iv fluids. A: since the line was connected to the patient's picc line, i was concerned for infection but luckily this patient is already on an antibiotic. It is also unfortunate that the patient will not be receiving any parenteral nutrition until they can order tpn for the following day. R: i recommend that this product be investigated so that this does not happen again. Since there was no obvious break in the filter, the reason for where and why it was leaking needs to be solved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEXT SET SMALLBORE .2MF PED
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 22244
MX 22244
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana 22244
MX 22244
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key10865040
MDR Text Key218273477
Report Number9616066-2020-20382
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K790108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number10011865
Device Catalogue Number10011865
Device Lot Number20045504
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-