MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM PUMP CONSOLE; HEART LUNG MACHINE

Model Number RESERVOIR LEVEL SENSOR

Device Problem No Audible Alarm (1019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

Spectrum medical inspected the sensor housing for signs of liquid ingress and tested functionality, no visible damage was found and no issue with functionality of the sensor.

Event Description

The blood reservoir level sensor failed to detect the safe flow level during use.The level sensor on the reservoir did not activate or alarm to stop pump.The user corrected the blood level in the reservoir.The user was also, running the case in safe flow mode with a safe flow bubble sensor that is placed on the outlet of the venous reservoir and another post oxygenator on the arterial line for extra safety levels.The low blood reservoir level never reached the safe flow bubble sensor which would have stopped the pump.No impact to the patient and case completed with no other issues.

• Brand Name: QUANTUM PUMP CONSOLE
• Type of Device: HEART LUNG MACHINE
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham rd east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: colleen powell ; harrier4, meteor business park; cheltenham road east; gloucester GL2 9 ; 44 1242387
• MDR Report Key: 12663734
• MDR Text Key: 279812066
• Report Number: 3006073153-2021-00006
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 05060434420893
• UDI-Public: 05060434420893
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: 173834
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RESERVOIR LEVEL SENSOR
• Device Catalogue Number: 43-000889-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR