MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM SMART OCCLUDER; CONSOLE

Model Number	QSOL
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
User noticed arterial flow was unavailable.This prompted the user to move bubble and flow sensors.User attempted to disable bubble alarm prior to moving but due to a suspected connection issue bubble alarm remained primed.On moving the bubble sensor, bubble alarm triggered causing occluder to close and pump to stop.User followed risk cotrols and resumed bypass 40 seconds after cessation.There was no harm to the patient.Spectrum medical considers pump stop a reportable malfunction.
Additional Manufacturer Narrative
On return of device, it was found that the cable had debris built up on both ends and "excess force" was requires to seat the cable correctly.Upon cleaning of cable and device the units were tested for repreated faults.Unit functioned as expeceted.

• Brand Name: QUANTUM SMART OCCLUDER
• Common Device Name: CONSOLE
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer (Section G): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer Contact: angus fletcher ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q-L ; UK GL29QL
• MDR Report Key: 20914129
• Report Number: 3006073153-2024-00142
• Device Sequence Number: 8581591
• Product Code: DTQ
• UDI-Device Identifier: 05060434420732
• UDI-Public: 05060434420732
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K190282
• 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): 12/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: QSOL
• Device Catalogue Number: 51-000022-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• 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
• Patient Sex: Unknown