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")

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem Insufficient Information (4580)

Event Date 12/31/2022

Event Type  Death  

Event 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
• Type of Device: 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
• MDR Text Key: 308143202
• Report Number: 3006073153-2023-00001
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 05060434421852
• UDI-Public: 05060434421852
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Death; Congenital Anomaly
• Patient Age: 3 DA