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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 2477-0000
Device Problems Fluid/Blood Leak (1250); Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2018
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 packed red blood cells were infusing and blood was noted on the floor.A crack was discovered at the top of the drip chamber where the tubing connects.No additional information is available.
 
Manufacturer Narrative
The customer report of a leak was confirmed.Visual inspection of the as-received sample observed dried blood residue atop the blood filter drip chamber.Inspection under magnification of the top of the drip chamber component observed no obvious damages or issues.During functional testing fluid was observed to leak out from one of the two tubing engagements to its corresponding inlet port on the top of the blood filter drip chamber component.The root cause was identified as due to an assembly issue of insufficient solvent being applied at the engagement of the tubing end.The customer report of a crack at the top of the drip chamber where the tubing connects was not confirmed.
 
Event Description
The customer reported packed red blood cells were infusing and blood was noted on the floor.A crack was discovered at the top of the drip chamber where the tubing connects.No additional information is available.
 
Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
 
Event Description
The customer reported packed red blood cells were infusing and blood was noted on the floor.A crack was discovered at the top of the drip chamber where the tubing connects.No additional information is 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 Key8387787
MDR Text Key137740929
Report Number9616066-2019-00463
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403233999
UDI-Public10885403233999
Combination Product (y/n)N
PMA/PMN Number
K894842
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 02/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2477-0000
Device Catalogue Number2477-0000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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