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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. MAXGUARD SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION 303, INC. MAXGUARD SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number UNKNOWN
Device Problem Material Separation (1562)
Patient Problem Blood Loss (2597)
Event Date 04/09/2019
Event Type  malfunction  
Event Description
Patient's drip line was changed out overnight using a bi-fuse. Around 0345, there was blood found all over the patient. Upon further investigation, the bi-fuse had come apart, causing the tubing to disconnect and blood to backup out of the open tubing onto the bed. The patient lost 80cc of blood. Labs were drawn to determine hct levels.
 
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Brand NameMAXGUARD
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd
san diego CA 92121
MDR Report Key9653276
MDR Text Key177169906
Report Number9653276
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/06/2019
Event Location No Information
Date Report to Manufacturer01/31/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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