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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 Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Although requested, device 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 24-hour epoch (combination of doxorubicin, etoposide, and vincristine) infusions have lengthened approximately 2 hours since changing to the low sorbing infusion set. The epoch volume is 500ml and it always runs at 20. 8ml/hr. The dosage of etoposide in the epoch bags ranges from 85-128mg. The clinicians have noticed an increase in air-in-line (ail) alarms since they started using the low sorbing set and alleged that the increased number of ail alarms caused the increased infusion times. Although the treatment time was prolonged, there was no report of patient harm. The customer also stated the pumps are working as intended for all other infusions before or after the epoch infusions, and the low sorb tubing is used for other 24 hour infusions without ail issues.
 
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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
mustafa omar
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key7422595
MDR Text Key105245020
Report Number9616066-2018-00454
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 03/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2018
Is this an Adverse Event Report? No
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 Received03/21/2018
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

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