MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM ; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number QUANTUM ROLLER PUMP - 6 INCH (QRP6)

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

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/04/2020

Event Type  malfunction  

Event Description

Heart-lung machine malfunctioned and created negative pressure in the circuit, which de-primed the oxygenator and sent air up the arterial limb.Line pressure alarm went off in the morning.Patient was clamped off bypass immediately and resumed full bypass 5 minutes later.During this time, volume was administered by anesthesia to help with low patient pressure.

• Brand Name: QUANTUM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; 481 munn road, suite 180; fort mill SC 29715
• MDR Report Key: 10634619
• MDR Text Key: 209995604
• Report Number: 10634619
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: QUANTUM ROLLER PUMP - 6 INCH (QRP6)
• Device Catalogue Number: 51-000013-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2020
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21 DA