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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION PRIMARY TUBING SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION PRIMARY TUBING SET SET, ADMINISTRATION, INTRAVASCULAR 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. The customer¿s complaint could not be confirmed because the product will not be returned for failure investigation. The root cause of this failure was not identified.
 
Event Description
It was reported during a site visit by a bd clinical consultant, that near the end of blood transfusions, an ¿occluded container side¿ alarm occurs. The tubing appears flattened inside of the pump module door upon opening the door to inspect the tubing. This is one of at least 3 occurrences. The staff recalls blood remaining in the bag on one occasion and potentially an empty bag with blood in the drip chamber on another occasion. These events occurred in the children¿s hospital outpatient services.
 
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Brand NamePRIMARY TUBING SET
Type of DeviceSET, 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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9629934
MDR Text Key191692913
Report Number9616066-2020-00280
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRI TUBING
Device Catalogue NumberPRI TUBING
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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

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