MAXPLUS * MP1000-C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-15 for MAXPLUS * MP1000-C manufactured by Carefusion 303, Inc..

Event Text Entries

[3544244] The port was cracked. Air is able to enter the line and cause bubbles. What was the original intended procedure? Iv connection. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3164275
• MDR Report Key: 3164275
• Date Received: 2013-05-15
• Date of Report: 2013-05-07
• Date of Event: 2013-05-06
• Report Date: 2013-05-07
• Date Reported to FDA: 2013-05-15
• Date Reported to Mfgr: 2013-06-12
• Date Added to Maude: 2013-06-12
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MAXPLUS
• Generic Name: CONNECTOR, TUBING, IV
• Product Code: OJA
• Date Received: 2013-05-15
• Returned To Mfg: 2013-05-10
• Model Number: *
• Catalog Number: MP1000-C
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: R
• Device Age: 1 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CAREFUSION 303, INC.
• Manufacturer Address: 3750 TORREY VIEW COURT SAN DIEGO CA 92130 US 92130

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-05-15