BARD HF-5000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-22 for BARD HF-5000 manufactured by Cr Bard Inc..

Event Text Entries

[3577] During cardiopulmonary bypass the bard hf-5000 hollow fiber membrane oxygenator failed to adequately oxygenate in spite of the fact that the f;02 was 1. 0, the p 02 could not be attained above 40mm hg. Device labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Device not serviced in accordance with service schedule. No data - regarding date last serviced. Service provided by: invalid data. Service records not 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, visual examination. Results of evaluation: component failure, telemetry failure, none or unknown, invalid data. Conclusion: device failure occurred and was related to event, device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6780
• MDR Report Key: 6780
• Date Received: 1993-07-22
• Date of Report: 1993-03-11
• Date of Event: 1993-03-09
• Date Facility Aware: 1993-03-09
• Report Date: 1993-03-11
• Date Reported to Mfgr: 1993-03-09
• Date Added to Maude: 1993-10-15
• 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: BARD
• Generic Name: MEMBRANE OXYGENATOR - HOLLOW FIBER
• Product Code: BYS
• Date Received: 1993-07-22
• Model Number: HF-5000
• Catalog Number: HF-5000
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 6463
• Manufacturer: CR BARD INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-07-22