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

Device Problems Detachment Of Device Component (1104); Defective Component (2292)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/02/2017

Event Type  malfunction  

Event Description

Carefusion maxplus (minibore) extension set came apart while in use at a non-connector site.The patient had unnecessary bleeding before it was noticed by family or rn.Defective equipment was given to central sterile processing department (cspd) who will be contacting the manufacturer and returning the defective tubing to them.

• Brand Name: MAXPLUS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 6618528
• MDR Text Key: 76882862
• Report Number: 6618528
• 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: 02/07/2017,05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other