MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM 12" ELITE WORKSTATION; BLOOD GAS MONITOR

Model Number	QFS 3/8 X 2.0M (ID 1/4" X WALL 1/16")
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/31/2022
Type of Reportable Event	Death
Event or Problem Description
Flow probe sensor, ecmo coordinator, reported that they had a 1/4" flow probe that was reading about half of the actual flow.The flow probe fs2000138 was the arterial flow probe, and the entire case it was reading around.200 lpm, which was the target flow they also had a venous flow probe (measured pre-shunt so this should be very close to the art flow) and an "alt flow" probe (shunt flow).An ecmo specialist eventually noticed the discrepancy between art and ven flows (no alarms set or charting of ven and alt routinely).They did some trouble shooting by attaching all flow probes to the arterial line, and the art flow was reading about half of what the other two flow probes were reading.They then replaced fs2000138 with a new flow probe, and this was reading the same as the venous flow probe.The specialist that set up the pump reported zeroing all flows before the case.They did not zero the replacement flow probe because they were on support.

• Brand Name: QUANTUM 12" ELITE WORKSTATION
• Common Device Name: BLOOD GAS MONITOR
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham rd 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: colleen powell ; harrier4, meteor business park; cheltenham rd east; gloucester, GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 16245369
• Report Number: 3006073153-2023-00001
• Device Sequence Number: 20420982
• Product Code: DRY
• UDI-Device Identifier: 05060434421852
• UDI-Public: 05060434421852
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/26/2023

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: QFS 3/8 X 2.0M (ID 1/4" X WALL 1/16")
• Device Catalogue Number: 51-000065-00
• 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: 01/05/2023
• Initial Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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; Congenital Anomaly
• Patient Age: 3 DA
• Patient Sex: Unknown