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

Model Number	QWS15S
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	01/28/2024
Type of Reportable Event	Death
Event or Problem Description
There was an event at (b)(6) hospital center where a patient expired while on cpb.The case was an aortic dissection.They were flowing between 5-6 lpm on quantum perfusion cp37 and the cross clamp was off.Then, the perfusionist noted that he could not get any flow and his rpms would not get any greater than 700.After the perfusionist failed to increase rpms, he then tried to hand crank but could not establish flow with the hand crank either.The patient expired a few minutes later.After the patient expired they noticed an "error message" on the level tab of the arterial pump tile.After the case, they closed the circuit loop and were able to hand crank without an issue.
Additional Manufacturer Narrative
The red-colored head of the level sensor came away from the venous reservoir triggering the safety pop up screen, which flashed current alarm conditions.In this condition, if the 'protected flow' safety is in place, the pump goes to zero flow.According to the logs, the user exited (dismissed) the screen after 4 seconds without disabling the level alarm.The pump's rpms cannot be increased during a level sensor error/alarm.Level alarm must first be resolved or disabled by the clinician before rpms can be increased.The system continued to notify the user of the level alarm condition for 8 minutes via a dynamic configuration dialog, flashing pump tile with 'protected level' icon, and an audible alarm (single beeps every 10 seconds).The level alarm condition was not rectified in time which meant that the reservoir was filled and overflowed whilst the pump rpm remained low, ultimately leading to the patient expiring.The volume in the reservoir continued to increase leading to an overflowing of the reservoir, the clinician than clamped out their cardiopulmonary bypass circuit.Then the perfusionist attempted to hand crank to induce flow to the patient, however, that turned out to be unsuccessful (potentially due to prior clamping of the arterial line in reaction to the overflowing reservoir).In the event of a level alarm, the clinicians are trained to look at their level to see how much volume is in the reservoir.If there is adequate volume they are trained to trouble shoot the level detector.Which in this case would be to secure it on the reservoir so it would read accurately, thus allowing the clinician to ramp up the pump rpms to the desired value.
Additional Manufacturer Narrative
The red-colored head of the level sensor came away from the venous reservoir triggering the safety pop up screen, which flashed current alarm conditions.In this condition, if the 'protected flow' safety is in place, the pump goes to zero flow.According to the logs, the user exited (dismissed) the screen after 4 seconds without disabling the level alarm.The pump's rpms cannot be increased during a level sensor error/alarm.Level alarm must first be resolved or disabled by the clinician before rpms can be increased.The system continued to notify the user of the level alarm condition for 8 minutes via a dynamic configuration dialog, flashing pump tile with 'protected level' icon, and an audible alarm (single beeps every 10 seconds).The level alarm condition was not rectified in time which meant that the reservoir was filled and overflowed whilst the pump rpm remained low, ultimately leading to the patient expiring.The volume in the reservoir continued to increase leading to an overflowing of the reservoir, the clinician than clamped out their cardiopulmonary bypass circuit.Then the perfusionist attempted to hand crank to induce flow to the patient, however, that turned out to be unsuccessful (potentially due to prior clamping of the arterial line in reaction to the overflowing reservoir).In the event of a level alarm, the clinicians are trained to look at their level to see how much volume is in the reservoir.If there is adequate volume they are trained to trouble shoot the level detector.Which in this case would be to secure it on the reservoir so it would read accurately, thus allowing the clinician to ramp up the pump rpms to the desired value.Update 03/29/2024 - investigation results: the results showed the protected level was triggered while safe level was still active, zero flow mode initiated and our safety window was launched onto the quantum workstation screen.The end user exited the screen without disabling the level or examining the level detector.Based on the protected triggering and safe level being active the protected level must have lost adherence to the reservoir.The alarms continued during this time in the pump tile.At this time the level in the reservoir over filled, which led the end user to clamp out the circuit.The end user ignored the flashing/audible alarms and went to hand cranking.They expressed that they had high line pressures, this could be due to a possible clamp or patient anatomy.The root cause of this event was ignoring the safety alarms that would have directed them to the level detector that lost adherence to the reservoir which was inhibiting them to increase rpm's.
Event or Problem Description
There was an event at (b)(6) hospital center where a patient expired while on cpb.The case was an aortic dissection.They were flowing between 5-6 lpm on quantum perfusion cp37 and the cross clamp was off.Then, the perfusionist noted that he could not get any flow and his rpms would not get any greater than 700.After the perfusionist failed to increase rpms, he then tried to hand crank but could not establish flow with the hand crank either.The patient expired a few minutes later.After the patient expired they noticed an "error message" on the level tab of the arterial pump tile.After the case, they closed the circuit loop and were able to hand crank without an issue.

• Brand Name: QUANTUM PUMP CONSOLE
• Common Device Name: HEART-LUNG MACHINE
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: asia lukuc ; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 18648997
• Report Number: 3006073153-2024-00001
• Device Sequence Number: 18192979
• Product Code: DTQ
• UDI-Device Identifier: 05060434420008
• UDI-Public: 05060434420008
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K173834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: QWS15S
• Device Catalogue Number: 51-000001-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR LEVEL SENSOR (QLV1) 43-000889-00; RESERVOIR LEVEL SENSOR (QLV1) 43-000889-XX
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown