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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 False Alarm (1013)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Customer states 15 occurrences in the last 2 months.
 
Event Description
It was reported that (b)(6) rn, reported experiencing air-in-line alarms with no visible air noted in the tubing with maintenance iv fluids.She stated she changed the iv pump channel and continued to experience air-in-line alarms.She had to change the iv set to get resolution of the air-in-line alarms.She stated this has happened to her approximately 15 times in the last 2 months.No additional information was available.
 
Event Description
It was reported that erin murray,rn, reported experiencing air-in-line alarms with no visible air noted in the tubing with maintenance iv fluids.She stated she changed the iv pump channel and continued to experience air-in-line alarms.She had to change the iv set to get resolution of the air-in-line alarms.She stated this has happened to her approximately 15 times in the last 2 months.There was no patient harm.No additional information was available.
 
Manufacturer Narrative
Supplemental created to update b5 and h6.
 
Manufacturer Narrative
Initially reportable but additional clinical review determined this to be not reportable.- supplemental mdr created to report non-reportability.
 
Event Description
It was reported that (b)(6), rn, reported experiencing air-in-line alarms with no visible air noted in the tubing with maintenance iv fluids.She stated she changed the iv pump channel and continued to experience air-in-line alarms.She had to change the iv set to get resolution of the air-in-line alarms.She further stated that this has happened to her approximately (15) times in the last (2) months.There was no patient harm.No additional information was available.
 
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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
MDR Report Key9793140
MDR Text Key194042393
Report Number9616066-2020-00755
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2020
Is this an Adverse Event Report? No
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 This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8100, 8015, THERAPY DATE UNKNOWN
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