HAEMOTRONIC TS 505/2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-28 for HAEMOTRONIC TS 505/2 manufactured by Haemotronic Ltd..

Event Text Entries

[17034481] One hour after patient began dialysis treatment on cobe century 2rx, blood was noted to be leaking from the top of the arterial chamber. The top of the chamber became completely disconnected. Approximate blood loss was 250cc. Arterial tubing was changed and 300 cc ns given for volume lost. 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. Results of evaluation: other. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7602
• MDR Report Key: 7602
• Date Received: 1994-01-28
• Date of Report: 1993-10-18
• Date of Event: 1993-09-24
• Date Facility Aware: 1993-09-24
• Report Date: 1993-10-18
• Date Reported to Mfgr: 1993-10-18
• Date Added to Maude: 1994-05-04
• 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: HAEMOTRONIC
• Generic Name: BLOOD TUBING
• Product Code: FKB
• Date Received: 1994-01-28
• Model Number: TS 505/2
• Lot Number: B93870 OR B924270
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-AUG-93
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7281
• Manufacturer: HAEMOTRONIC LTD.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-01-28