HOSPAL MEDICAL BSM/22 SC UNKNOWN OR NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-02-25 for HOSPAL MEDICAL BSM/22 SC UNKNOWN OR NA manufactured by Hospal Medical Cobe Labs/gambro Healthcare.

Event Text Entries

[19236215] Pt was undergoing continous venous hemo dialysis ultrafiltration treatments over a period of several days. Pt gained weight during this period, 45 kg in total. The amounts of fluid consumed are as follows: 19. 5 liters on 8/31/99, 12. 5 liters on 9/1/99, 31. 5 liters on 9/2/99, 3. 0 liters on 9/3/99. Pt was critically ill, and was somewhat compromised by the excessive weight gain. Expired 4 days later.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 266344
• MDR Report Key: 266344
• Date Received: 2000-02-25
• Date of Report: 2000-02-22
• Date of Event: 1999-08-31
• Date Facility Aware: 1999-09-06
• Report Date: 2000-02-22
• Date Added to Maude: 2000-03-03
• 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: BIOMEDICAL ENGINEER
• 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: HOSPAL MEDICAL
• Generic Name: C.V.V.H. DIALYSIS
• Product Code: FKQ
• Date Received: 2000-02-25
• Model Number: BSM/22 SC
• Catalog Number: UNKNOWN OR NA
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 3.0 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 257842
• Manufacturer: HOSPAL MEDICAL COBE LABS/GAMBRO HEALTHCARE
• Manufacturer Address: 1185 OAK ST. LAKEWOOD CO 802154498 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death; 2. Life Threatening	2000-02-25