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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS GRAVITY ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION ALARIS GRAVITY ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 10010903
Device Problem Obstruction of Flow (2423)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 02/22/2019
Event Type  malfunction  
Manufacturer Narrative
Perfusion manager.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.Although requested, patient demographics not provided.
 
Event Description
The customer reported that when priming the tubing with the roller clamp opened the tubing remains stuck together and would not separate during priming.There was a 10-20 minute delay in patient treatment.There was no harm.
 
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Brand Name
ALARIS GRAVITY 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
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8401736
MDR Text Key138408626
Report Number9616066-2019-00685
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203020879
UDI-Public7613203020879
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K882302
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10010903
Device Catalogue Number10010903
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
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