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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INFUSION
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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INFUSION Back to Search Results
Model Number PRI TUBING
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer.The customer declined to return the device for failure investigation.The root cause of this failure was not identified.
 
Event Description
It was reported that the facility offers two different fentanyl concentrations and they are trying to determine if the device was programmed appropriately to rule out diversion during a fentanyl infusion on a male patient in the icu.
 
Event Description
It was reported that the facility offers two different fentanyl concentrations and they are trying to determine if the device was programmed appropriately to rule out diversion during a fentanyl infusion on a male patient in the icu.
 
Manufacturer Narrative
Correction: supplemental emdr created to state that the pri tubin is not a suspect disposable for the file.Emdr 307148 was previously submitted that documented the correct suspect device.Section a.1; a.2; a.4 requested but not provided.B.3 requested but not provided.
 
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Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Type of Device
SET, ADMINISTRATION, INFUSION
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8658559
MDR Text Key146915547
Report Number9616066-2019-01522
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
Report Date 05/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2019
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
8015,THERAPY DATE UNKNOWN
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