* A209Y/V803

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-07 for * A209Y/V803 manufactured by Nipro Corporation.

Event Text Entries

[15122383] Patient attached to dialysis machine for ten minutes. Rn at her side stated she "went out" and had a syncopal episode that lasted 30 seconds. A rapid response was called and she was transferred into the icu. Dialysis machine and disposables taken out of service. They arrived today to do pm on the dialysis machine and it was cleared for use. They also took a report to the fda.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4169164
• MDR Report Key: 4169164
• Date Received: 2014-10-07
• Date of Report: 2014-10-07
• Date of Event: 2014-10-02
• Report Date: 2014-10-07
• Date Reported to FDA: 2014-10-07
• Date Reported to Mfgr: 2014-10-14
• Date Added to Maude: 2014-10-14
• 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: 3
• 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 Sequence Number: 1

• Brand Name: *
• Generic Name: BLOOD TUBING SET
• Product Code: FIB
• Date Received: 2014-10-07
• Model Number: *
• Catalog Number: A209Y/V803
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NIPRO CORPORATION
• Manufacturer Address: 3150 N.W. 107 AVE, MIAMI FL 33172 US 33172

Device Sequence Number: 2

• Brand Name: OPTIFLUX
• Generic Name: DIALYZER
• Product Code: KDI
• Date Received: 2014-10-07
• Model Number: *
• Catalog Number: F200NR
• Lot Number: 14HU04002
• ID Number: *
• Device Availability: N
• Device Age: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: FRESENIUS MEDICAL CARE
• Manufacturer Address: 920 WINTER STREET, WALTHAM MA 02451 US 02451

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-10-07