CENTRYSYSTEM BLOOD TUBING 018-445-500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-03-15 for CENTRYSYSTEM BLOOD TUBING 018-445-500 manufactured by Cgh Medical.

Event Text Entries

[19962676] The venous level dectect alarm sounded (on the delivery system). The blood level was visually found to be normal. Multiple attempt were made. Unsuccessfully, to clear the alarm. During this alarm condition safety back ups will not allow the blood pump to run, therefore, the entire extracorpreal system clotted during attempts to clear the alarm. This resulted in an estimated blood loss of apx. 250mls for the patient. After the system was torn down examination of the blood lines showed that the venous drip chamber filter had become to sound. This same failure with the same alarm condition happened on two other patients, but no blood loss resulted. Pt. With loss showed no adverse symptoms nor required transfusion. Device 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 evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination, none or unknown. Results of evaluation: manufacturing, telemetry failure, none or unknown. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor, other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5372
• MDR Report Key: 5372
• Date Received: 1993-03-15
• Date of Report: 1993-01-29
• Date of Event: 1992-10-14
• Date Facility Aware: 1992-10-14
• Report Date: 1993-01-29
• Date Reported to Mfgr: 1992-10-16
• Date Added to Maude: 1993-07-09
• 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: CENTRYSYSTEM BLOOD TUBING
• Generic Name: DIALYZER BLOOD LINES
• Product Code: FKB
• Date Received: 1993-03-15
• Catalog Number: 018-445-500
• Lot Number: 08 X 3363
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5068
• Manufacturer: CGH MEDICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-03-15