COBE CENTRY 2 RX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-04-08 for COBE CENTRY 2 RX manufactured by Cobe Laboratories.

Event Text Entries

[21629618] Patient removed arterial needle which allowed air to enter extra corporeal circuit, when the column of air reached the air detector it passed to within 12 inches before the audible alarm and the clamp engaged. No aiar entered the patient's venous system. All alarm functions had been tested and were in good working order prior to initiation of patient's dialysisdevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-dec-91. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed, visual examination. Results of evaluation: mechanical problem, none or unknown, none or unknown, other. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: no. Corrective actions: device repaired and put back in service, device temporarily removed from service, inserviced by biomedical engineering dept. Staff. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 461
• MDR Report Key: 461
• Date Received: 1992-04-08
• Date of Report: 1992-03-26
• Date of Event: 1992-03-12
• Date Facility Aware: 1992-03-12
• Report Date: 1992-03-26
• Date Reported to FDA: 1992-03-26
• Date Reported to Mfgr: 1992-03-26
• Date Added to Maude: 1992-05-01
• 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: COBE CENTRY 2 RX
• Product Code: CAP
• Date Received: 1992-04-08
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 455
• Manufacturer: COBE LABORATORIES

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-04-08