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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 Problem Insufficient Flow or Under Infusion (2182)
Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914)
Event Date 02/20/2019
Event Type  Death  
Manufacturer Narrative
Concomitant medical product: baxter iv bags, td (b)(6) 2019. Customer declined to provide patient demographics "levophed dependent". 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
It was reported that frequent ail (air in line) alarms occurred on a hemodynamically unstable icu patient. Levophed (16mg/ 250 ml ns) was infusing continuously at a rate of 180 ml/hr, as the patient was dependent on large amounts of levophed to maintain a sustainable blood pressure "compatible with life. " the device was alarming ail every 20 -30 minutes, however there was no visible air noted in the line. The nurse removed the tubing from the device and flicked it to troubleshoot the ail alarms; they were unable to flush the line as the iv bag was small. The line was eventually removed and the tubing and devices were replaced. Within seconds of stopping, the infusion, the patient immediately experienced a decrease in blood pressure by 50 mmhg (bp not provided), necessitating infusion of the levophed by gravity while troubleshooting the al alarms for 30 minutes. This caused a delay in medication delivery as well as a delay in obtaining a stat ct scan. The patient died later that day; the nurse felt the outcome was not related to the device, however it would have been if the levophed was not able to be run intermittently by gravity.
 
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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 Key8423321
MDR Text Key138886531
Report Number9616066-2019-00751
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
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: 03/14/2019 Patient Sequence Number: 1
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