FOCUS 160 01-9858

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-07 for FOCUS 160 01-9858 manufactured by National Medical Care.

Event Text Entries

[3304] The patient's pre dialysis assessment was negative. 20 minutes into the dialysis treatment the patient complained of shaking chills. The patient's pre dialysis temperature was not taken. Her temperature at the time of the incident was 100. 8 f. Maximum temperature was 101. 3. The patient was given dyleral, blood cultures and millyore dialpate cultures were taken dealyus was terminated. Pyrogen testing was not done. Dialysis treatment was resumed using a new system. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8027
• MDR Report Key: 8027
• Date Received: 1994-03-07
• Date of Report: 1993-08-05
• Date of Event: 1993-07-30
• Date Facility Aware: 1993-08-05
• Report Date: 1993-08-05
• Date Added to Maude: 1994-06-20
• 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: 0
• Initial Report to FDA: 0
• 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: FOCUS
• Generic Name: HOLLOW FIBER DIALYZER
• Product Code: FCT
• Date Received: 1994-03-07
• Model Number: 160
• Catalog Number: 01-9858
• Lot Number: NOT AVAILABLE
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7702
• Manufacturer: NATIONAL MEDICAL CARE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-03-07