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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SE ADMINSTRATION INTRAVASCULAR
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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SE ADMINSTRATION INTRAVASCULAR Back to Search Results
Model Number PRI TUBING
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/06/2019
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.Although requested, patient demographics not provided.
 
Event Description
It was reported that in the anesthesia work room, the pump continued to administer dopamine "free flow" while the pump was paused and tubing clamped.The tubing appeared to be assembled and positioned correctly.The patient was not involved.There was an unsuccessful attempt to duplicate the problem with distilled water.The pump was paused 4 times at a 999 rate / 12 vtbi, 30-45 seconds in between attempts.There were no excess drips after pause.The pumps had past preventative maintenance inspection.Although requested, no further information has been received.
 
Manufacturer Narrative
Additional information: added date of event.Correction from initial to: remove 510k information.
 
Event Description
It was reported that in the anesthesia work room, the pump continued to administer dopamine "free flow" while the pump was paused and tubing clamped.The tubing appeared to be assembled and positioned correctly.The patient was not involved.There was an unsuccessful attempt to duplicate the problem with distilled water.The pump was paused 4 times at a 999 rate / 12 vtbi, 30-45 seconds in between attempts.There were no excess drips after pause.The pumps had past preventative maintenance inspection.Although requested, no further information has been received.
 
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Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Type of Device
SE ADMINSTRATION INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8449456
MDR Text Key139752730
Report Number9616066-2019-00839
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2019
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
(2)8100,8015,PRI TUBING,; (2)8100,8015,PRI TUBING,
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