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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number PRI TUBING
Device Problems Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)
Patient Problems Chest Pain (1776); Dyspnea (1816); High Blood Pressure/ Hypertension (1908)
Event Date 10/01/2018
Event Type  Injury  
Manufacturer Narrative
Although requested, product has not been received. A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
The customer reported that while the pump was turned off but connected to the patient, the 250ml bag of neo-synephrine (40mg/250ml) continued to drip from the unclamped tubing. When the nurse noticed fluid flowing in the drip chamber, she stopped it by closing the clamp. The patient became hypertensive, 220/110, and exhibited chest pain and shortness of breath. All vasoactive iv medications were stopped immediately. The patient was also receiving epinephrine and vasopressin; neither appeared to be infusing at a rate greater than intended. The patient was awake and alert. In addition to the other interventions that were in place (oxygen and monitoring) the patient was administered iv morphine.
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8044337
MDR Text Key126349533
Report Number9616066-2018-02097
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRI TUBING
Device Catalogue NumberPRI TUBING
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/06/2018 Patient Sequence Number: 1
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