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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS PUMP MODULE PUMP, INFUSION
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CAREFUSION SD ALARIS PUMP MODULE PUMP, INFUSION Back to Search Results
Model Number 8100
Device Problems Insufficient Flow or Under Infusion (2182); No Audible Prompt/Feedback (2282)
Patient Problems High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Respiratory Failure (2484)
Event Date 03/19/2021
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted once the evaluation is completed. Diagnosis- acute respiratory failure with hypoxemia. Evaluation pending.
 
Event Description
It was reported that after several hours of a norepinephrine infusion being run, the bag remained full. The rate was 63 ml/hour with a 250 ml bag, therefore the bag should have required replacement every 4 hours. Upon investigation, the tubing inside the channel was sealed together in two areas obstructing flow. During administration the pump was not alarming for occlusion, or empty container. Patient required administration of additional, new drug, vasopressin, for blood pressure support and to stabilize patient's blood pressure, while the tubing was not functioning correctly. The patient remained in icu, ultimately no effect once error was detected. As stated by customer. No further information is available.
 
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Brand NameALARIS PUMP MODULE
Type of DevicePUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
brett wilko
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key11689294
Report Number2016493-2021-502709
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10885403810015
UDI-Public10885403810015
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8100
Device Catalogue Number8100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Patient Age65 YR
Patient Weight69
Patient Outcome(s) Required Intervention;
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