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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALARIS MEDICAL SYSTEMS, INC. ALARIS 8100 INFUSION PUMP MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM

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ALARIS MEDICAL SYSTEMS, INC. ALARIS 8100 INFUSION PUMP MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM Back to Search Results
Device Problems Crack (1135); Fracture (1260)
Patient Problem Death (1802)
Event Date 01/25/2021
Event Type  Death  
Event Description
The device had failed and was found to have cracked posts on the bezel. Patient involvement was reported. The reported issues states: in the last two weeks, i have had two pumps from avante fail because of cracked posts on the bezels, one which is currently involved in a patient incident. Upon further investigation, it was reported that the patient expired. No additional patient event or details are available at this time. A follow up report will be submitted upon completion of device evaluation and additional information obtained.
 
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Brand NameALARIS 8100 INFUSION PUMP
Type of DeviceMEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM
Manufacturer (Section D)
ALARIS MEDICAL SYSTEMS, INC.
10221 waterridge circ.
san diego CA 92121
Manufacturer (Section G)
AVANTE HEALTH SOLUTIONS
212 avenida fabricante
san clemente CA 92672
Manufacturer Contact
jenna vargas
212 avenida fabricante
san clemente, CA 92672
8004495328
MDR Report Key11228111
MDR Text Key228602611
Report Number3007409280-2021-00001
Device Sequence Number1
Product Code FRN
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K030459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other Health Care Professional
Remedial Action Recall
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 Received01/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received01/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/25/2021 Patient Sequence Number: 1
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