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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ SECONDARY SET INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ SECONDARY SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 72213N
Device Problem Backflow (1064)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2022
Event Type  malfunction  
Event Description
It was reported that 2 bd alaris¿ secondary sets had issues with their potassium flowing into the secondary drip chamber despite the infusion not being initiated. The following information was provided by the initial reporter: "utilized established primary/secondary tubing to administer iv potassium to patient backflushed secondary iv tubing that had previously been used for zosyn piggybacked potassium to ns bag that was infusing kvo rate at the time observed the potassium immediately began rapidly dripping into secondary tubing drip chamber despite infusion not yet being initiated on ivac noted fluid level rising in drip chamber of primary tubing immediately closed roller clamp to primary tubing clamped roller clamp for secondary tubing noted that tubing appeared to be setup according to facility policy including extension hook for primary bag being fully extended, and iv pole raised to appropriate height above ivac disconnected primary tubing from patient iv occurred with another new setup and then on the third new setup it functioned correctly".
 
Manufacturer Narrative
The reported lot# 21089263 was not found for the reported catalog# 72213n. Medical device expiration date: unknown. The customer's address is unknown. (b)(6) has been used as a default. Fda notified?: the initial reporter also notified the fda via medwatch # mw5107129. 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.
 
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Brand NameBD ALARIS¿ SECONDARY SET
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13954541
MDR Text Key288275698
Report Number9616066-2022-00321
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K790582
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 04/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72213N
Device Catalogue Number72213N
Device Lot NumberSEE SECTION H10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/19/2022
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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