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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 Problems Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Patient Problem No Information (3190)
Event Date 03/03/2020
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. Although requested, patient demographics were not provided.
 
Event Description
It was reported that the tubing ballooned. The nurse stated that while infusing, she found the blue part was not sitting in the chamber but on top of the chamber causing the bubble to form. The tubing was also kinked, causing the pump to continue to alarm for occlusion on the patient side. Although requested, no additional event and/or patient information was provided.
 
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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 Key9913495
MDR Text Key190314687
Report Number9616066-2020-01115
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 Pharmacist
Type of Report Initial,Followup
Report Date 03/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2020
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? Yes
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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