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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 2426-0500
Device Problems Material Separation (1562); Separation Failure (2547)
Patient Problem 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 device be received for evaluation.
 
Event Description
It was reported that the tubing came apart during use.Patient impact was requested, but not yet provided.
 
Event Description
It was reported that the tubing set separated at the upper fitment.Although requested, there has been no impact to patient response or additional event information made available to date.
 
Manufacturer Narrative
Additional information added; h.6.(device code) no product will be returned.The customer complaint of tubing set separated at the upper fitment was confirmed.Photo provided by the customer shows separation between the silicone segment and the upper fitment.The root cause of this failure was not identified.
 
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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 Key9689427
MDR Text Key191556996
Report Number9616066-2020-00435
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203020992
UDI-Public7613203020992
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2426-0500
Device Catalogue Number2426-0500
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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