SARNS 13530

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-04 for SARNS 13530 manufactured by 3m Sarns, Inc..

Event Text Entries

[5706] Patient was undergoing a coronary bypass graft procedure and experienced a sudden drop in blood pressure. It was noted that the arterial line of the heart lung bypass system was filled with foam and air bubbles. The perfusionist noted that the venous reservoir was nearly empty. Despite the presence of a blood level detector on the venous reservoir and an air bubble detector on the arterial line, neither detector was triggered and no alarm sounded. The surgeon and anesthesiologist initiated maneuvers to prevent air emboli from affecting the patient. There was no adverse outcome to patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 16651
• MDR Report Key: 16651
• Date Received: 1994-02-04
• Date of Report: 1994-01-26
• Date of Event: 1993-11-19
• Date Facility Aware: 1993-11-19
• Report Date: 1994-01-26
• Date Reported to Mfgr: 1993-11-19
• Date Added to Maude: 1994-10-07
• 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: 3
• Initial Report to FDA: 3
• 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: SARNS
• Generic Name: AIR BUBBLE DETECTOR SYSTEM
• Product Code: FJF
• Date Received: 1994-02-04
• Model Number: 13530
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 24 MO
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 16584
• Manufacturer: 3M SARNS, INC.
• Manufacturer Address: 6200 JACKSON ROAD ANN ARBOR MI 48103 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-02-04