MAUDE Adverse Event Report: CIRCULATORY TECHNOLOGY INC BIGGER BETTER-BLADDER; RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Model Number BBB38

Device Problems Gas/Air Leak (2946); Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2019

Event Type  malfunction  

Event Description

The bigger better bladder in the ecmo circuit has an air chamber on the outside for equilibrating the pressures during the run that ensures appropriate negative pressure on the system.During the previous night, specialist has trouble maintaining the air chamber to the right pressure.We found the air chamber pigtail connector was leaking, requiring the bladder to be changed on the circuit.The patient was off bypass for 1 minute and 20 seconds during the change, but tolerated the brief time off without incident.Possibly a manufacturer defect.Event was related to a defective consumable which was replaced with no event.Machine did not malfunction; no further action required by biomed.

• Brand Name: BIGGER BETTER-BLADDER
• Type of Device: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CIRCULATORY TECHNOLOGY INC; 21 singworth st.; oyster bay NY 11771
• MDR Report Key: 8934600
• MDR Text Key: 155644229
• Report Number: 8934600
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BBB38
• Device Catalogue Number: BBB38
• Device Lot Number: 5300-S19955
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8395 DA