VOLUMETRIC INFUSION CONTROLLER 262+

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-12-19 for VOLUMETRIC INFUSION CONTROLLER 262+ manufactured by Ivac Medical Systems.

Event Text Entries

[36309] An overinfusion occurred. The user facility reported that the pt may have contributed to the incident by manipulating the device during use. There was no resultant pt complication.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2016493-1996-00069
• MDR Report Key: 59652
• Report Source: 05,06
• Date Received: 1996-12-19
• Date of Report: 1996-12-19
• Date of Event: 1996-11-19
• Date Facility Aware: 1996-11-19
• Report Date: 1996-12-19
• Date Mfgr Received: 1996-11-20
• Device Manufacturer Date: 1993-12-01
• Date Added to Maude: 1997-01-03
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VOLUMETRIC INFUSION CONTROLLER
• Generic Name: CONTROLLER
• Product Code: LDR
• Date Received: 1996-12-19
• Returned To Mfg: 1996-11-25
• Model Number: 262+
• Catalog Number: 262+
• Lot Number: NA
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 36 MO
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 60072
• Manufacturer: IVAC MEDICAL SYSTEMS
• Manufacturer Address: 10221 WATERIDGE CIRCLE SAN DIEGO CA 92121 US
• Baseline Brand Name: VOLUMETRIC INFUSION CONTROLLER
• Baseline Generic Name: INFUSION CONTROLLER
• Baseline Model No: 262+
• Baseline Catalog No: 262+
• Baseline ID: NA
• Baseline Device Family: INFUSION CONTROLLER
• Baseline Shelf Life Contained: A
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K894487
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1996-12-19