2008 MACHINE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-03 for 2008 MACHINE manufactured by .

Event Text Entries

[4369036] Inappropriate saline bag filing of questionable substance.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3792891
• MDR Report Key: 3792891
• Date Received: 2014-04-03
• Date of Report: 2014-03-26
• Date of Event: 2014-03-26
• Date Facility Aware: 2014-03-26
• Report Date: 2014-03-26
• Date Reported to FDA: 2014-03-27
• Date Added to Maude: 2014-05-07
• 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
• 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: 2008 MACHINE
• Generic Name: 2008 MACHINE
• Product Code: FII
• Date Received: 2014-04-03
• Lot Number: 115496
• Device Availability: Y
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0

Device Sequence Number: 2

• Brand Name: SALINE
• Generic Name: SALINE
• Product Code: KDI
• Date Received: 2014-04-03
• Lot Number: 13JUL06062
• Device Sequence No: 2
• Device Event Key: 0

Device Sequence Number: 3

• Brand Name: TUBING
• Generic Name: TUBING
• Product Code: FJK
• Date Received: 2014-04-03
• Lot Number: 13PRO1262
• Device Sequence No: 3
• Device Event Key: 0

Device Sequence Number: 4

• Brand Name: DIALYZER
• Generic Name: DIALYZER
• Product Code: KDI
• Date Received: 2014-04-03
• Lot Number: 13PU01008 F160NR
• Device Sequence No: 4
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-04-03