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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 Fluid Leak (1250)
Patient Problem Death (1802)
Event Date 02/26/2018
Event Type  Death  
Manufacturer Narrative
Although requested, the affected product has not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
The customer reported that an infusion of 250ml of norepinephrine (8mg) was noted to have leaked. The patient had been weaned off the medication earlier in the day and the pump was turned off. They noticed drops of moisture on the iv pump that the tubing was programmed on and upon further investigation they found the leak to be coming from the y site of the tubing. There was no patient harm as a result of this event however the patient did pass away a few days later. The customer stated the tubing malfunction did not cause the patient¿s demise.
 
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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 Key7346803
MDR Text Key102702991
Report Number9616066-2018-00303
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
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 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2018
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
Date Manufacturer Received02/27/2018
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: 03/16/2018 Patient Sequence Number: 1
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