GESCO *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-06 for GESCO * manufactured by Utah Medical Products, Inc..

Event Text Entries

[2998634] Gesco dialysis system leaking at the stopcock towards the drain line. Md notified. Peritoneal dialysis cultures drawn, antibiotics initiated, and a new gesco system hung.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2842693
• MDR Report Key: 2842693
• Date Received: 2012-10-06
• Date of Report: 2012-10-06
• Date of Event: 2012-09-06
• Report Date: 2012-10-06
• Date Reported to FDA: 2012-10-06
• Date Added to Maude: 2012-11-21
• 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: GESCO
• Generic Name: PERITONEAL DIALYSIS SET, NEONATAL
• Product Code: FKO
• Date Received: 2012-10-06
• Returned To Mfg: 2012-09-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 2 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UTAH MEDICAL PRODUCTS, INC.
• Manufacturer Address: 7043 SOUTH 300 WEST MIDVALE UT 84047 US 84047

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-10-06