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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 3SS CV INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D 3SS CV INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2426-0007
Device Problem Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. 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.
 
Event Description
It was reported that the as lvp 20d 3ss cv experienced air in line. The following information was provided by the initial reporter: the previous infusion was beeping but had some medication left in the bottle so the old bottle was removed and the new bottle was spiked. She completed her scanning (scanned patient, bottle and pump), checked the rate (green screen) and started the new infusion. She did report that she saw drips falling in the tubing drip chamber the pump module was not opened and the iv set was not changed. She returned to the patients room 30-40 minutes later to transport the patient and found pump module alarming for air-in-line. The bottle was empty and she observed air in the tubing. At that point she noticed the patient was slumped and a rapid response was called. She paused the pump module and checked for leaks of the iv set and the line was still ¿good. ¿ the nurse was instructed to monitor the patient¿s heart rate and blood pressure and fluids were administered. The patient needed minimal intervention and no patient harm. Iv set was misloaded in the pump module. Medication was a glass bottle of precedex 400mcg/m. Iv set vent was in closed position. No obvious signs of fluid in the pumping segment. Start date and time sticker on precedex iv set 5/23 1400.
 
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Brand NameAS LVP 20D 3SS 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 Key12453011
MDR Text Key270917368
Report Number9616066-2021-52001
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 company representative,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0007
Device Catalogue Number2426-0007
Device Lot NumberUNKNOWN
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 Received08/13/2021
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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