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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 2426-0007
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Tachycardia (2095)
Event Date 09/05/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant product(s): a 250ml baxter bag ndc 0338-0049-02, lot number y273193, exp dec 19 0. 9%, sodium chloride. The affected product has been received and the evaluation is pending. A follow up report will be submitted once the evaluation is completed.
 
Event Description
The customer reported they were attempting to associate a levophed 16 mg/250 ml infusion with an alaris device and received a communication error #9007 message. The infusion had not yet been started because of the error, however the medication still infused. It was stated "bag not as full as should be for just attempting to start medication. " the customer reported they use pump integration (presumed to mean interoperability). The patient had an elevated blood pressure, elevated heart rate, and some hypoxia which the rn suspected was caused by the bolus of medication. The patient's condition resolved to baseline vitals at approximately 1010, which was within 20 minutes of the first abnormal vital sign at 0954. A new data set had been released at the facility (b)(6) 2018, the day before the event.
 
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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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key7920852
MDR Text Key122147446
Report Number9616066-2018-01846
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0007
Device Catalogue Number2426-0007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2018
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: 09/28/2018 Patient Sequence Number: 1
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