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

Catalog Number MZ5309

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/25/2016

Event Type  malfunction  

Event Description

Tubing leaked and blood loss occurred.Maintenance fluids were running; discovered when nurse entered the room and saw blood on the floor, saturated half of a towel, the patient was asymptomatic, the tubing was changed.

• Brand Name: MAXZERO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 5750802
• MDR Text Key: 48224178
• Report Number: 5750802
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2016,05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MZ5309
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 168