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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 Device Alarm System (1012); False Alarm (1013); Defective Alarm (1014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/27/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: baxter iv bags, iv flush syringe.Customer declined to answer patient demographics.Critically ill icu patient.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
It was reported that the nurse experienced frequent ail (air in line) alarms in the early am on two continuous primary infusions; levophed 8mg/250ml ns at 5 ml/hr, and cisatracurium 100mg/100ml at 6 ml/hr.The patient required both medications urgently, and was critically ill; therefore the levophed bag was not warmed to room temperature.The ail alarms occurred continuously approximately 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 both the tubing and devices were replaced.Although the nurse stated there was no harm to the critically ill icu patient, there was a significant delay delivering both emergent infusions.
 
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Brand Name
ALARIS® PUMP MODULE ADMINISTRATION SET
Type of Device
SET, 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 Key8424962
MDR Text Key138936946
Report Number9616066-2019-00750
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
UNKNOWN
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 Received03/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPRI TUBING
Device Catalogue NumberPRI TUBING
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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 Sequence Number1
Treatment
(2) 8100, 8015, PRI TUBING, THERAPY DATE (B)(6) 2019
Patient Outcome(s) Other;
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