*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-02-06 for * manufactured by Gambro Dasco S.p.a., Monitor Division.

Event Text Entries

[17237257] Improvements to increase the robustness of the hydraulic connectors has been approved by gambro dasco and will be implemented in the field. This event is being reported as "malfunction" under the mdr 2-year rule, regardless of any pt injury.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 9616240-2008-00010
• MDR Report Key: 1012278
• Report Source: 05,06,07
• Date Received: 2008-02-06
• Date Mfgr Received: 2008-01-08
• Device Manufacturer Date: 2002-09-01
• Date Added to Maude: 2008-03-14
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: FRANCESCO BARDELLI
• Manufacturer Street: VIA MODENESE, 66
• Manufacturer City: MEDOLLA (MO) I-41036
• Manufacturer Country: IT
• Manufacturer Postal: I-41036
• Manufacturer Phone: 53550111
• Manufacturer G1: GAMBRO DASCO
• Manufacturer Street: VIA MODENESE, 66
• Manufacturer City: MEDOLLA (MO) I41036
• Manufacturer Country: IT
• Manufacturer Postal Code: I41036
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: *
• Product Code: FID
• Date Received: 2008-02-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 979500
• Manufacturer: GAMBRO DASCO S.P.A., MONITOR DIVISION
• Manufacturer Address: VIA MODENESE,66 MEDOLLA IT

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-02-06