ABBOTT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-02 for ABBOTT * manufactured by Abbott Laboratories.

Event Text Entries

[43063] Using iv controller, volume cleared at 1800, new iv bag d5lr 1000cc had been hung at 1715. Pump alarmed at 1855, since 1800, 900cc had infused, rate was set correctly on pump.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 66284
• MDR Report Key: 66284
• Date Received: 1997-01-02
• Date of Report: 1996-08-26
• Date of Event: 1996-08-17
• Date Facility Aware: 1996-08-17
• Report Date: 1996-08-26
• Date Reported to Mfgr: 1996-08-26
• Date Added to Maude: 1997-02-05
• 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
• Reporter Occupation: RISK MANAGER
• 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: ABBOTT
• Generic Name: IV CONTROLLER
• Product Code: LDR
• Date Received: 1997-01-02
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 10 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 66362
• Manufacturer: ABBOTT LABORATORIES
• Manufacturer Address: BLDG AP30 200 ABBOTT PARK RD ABBOTT PARK IL 600643537 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-01-02