MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM WORKSTATION ELITE; PATIENT MONITOR

Model Number	QWS12E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/30/2024
Type of Reportable Event	Death
Event or Problem Description
A patient was placed on ecmo on the september 30th, at approx 2:15 am, and transported to cticu where the equipment was plugged into the wall outlet and gas lines were hooked up to the wall gas source.At this point everything was operating correctly, and the patient seemed relatively stable whilst receiving blood for a concern of possible volume loss.At 5:03 am the perfusionist received a phone call from a nurse who said that the patient was to have their chest opened at bedside and that a cell saver was required.They also said that the pump was off and they established that the workstation and the ventilation module were also off.The blood in the circuit appeared dark.The nurse was unable to determine how long the system had been off for at that point.She proceeded to connect the gas line directly to the o2 tank and set the sweep to 1 l/min.When the perfusionist joined them, the emergency had begun and the sweep continued to be set at 1 l/min, the perfusionist changed it to the previous setting of 3 l/min and tried to recover the old case.The perfusionist powered the workstation and the ventilation module off and rebooted, after which they were able to find the proper case in the recovery section.They reset all the safety parameters on the ventilation module.The patient was opened and had substantial blood loss.A cell saver was also used during the efforts to save the patient.The clinical team attempted to rush the patient to the or, but the situation was deemed unrecoverable due to massive blood loss and inability to get rhythm.

• Brand Name: QUANTUM WORKSTATION ELITE
• Common Device Name: PATIENT MONITOR
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; 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: 20598596
• Report Number: 3006073153-2024-00090
• Device Sequence Number: 6568172
• Product Code: DRY
• UDI-Device Identifier: 05060434422309
• UDI-Public: 05060434422309
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K202557
• 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
• Report Date (Section B): 11/04/2024

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: QWS12E
• Device Catalogue Number: 51-000094-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 11/04/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown