BAXTER BMLLA *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-02-02 for BAXTER BMLLA * manufactured by Baxter Healthcare Corp. Renal Product Svc.

Event Text Entries

[17830598] The renal blood pump, continuous renal replacement therapy, showed codes c-21, e-23, technical code shows check light on every 1-2 mins. Baxter technician support replaced current board, and recalibrated the machine but the machine failed to function. The pt was placed on conventional dialysis.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1021060
• MDR Report Key: 316020
• Date Received: 2001-02-02
• Date of Report: 2001-02-01
• Date of Event: 2001-01-29
• Date Added to Maude: 2001-02-16
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BAXTER
• Generic Name: BLOOD MONITOR
• Product Code: FIR
• Date Received: 2001-02-02
• Model Number: BMLLA
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 305578
• Manufacturer: BAXTER HEALTHCARE CORP. RENAL PRODUCT SVC
• Manufacturer Address: 8040 BRYAN DAIRY RD LARGO FL 33777 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2001-02-02