MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM WORK STATION; BLOOD GAS MONITOR

Model Number	QWS12E
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Perfusionist reported that they were unable to adjust rpm or turn on bubble sensor of the centrifugal pump, when using the touch screen.The issue spontaneously resolved itself on the first occurrence.We deem inability to control the pump a reportable occurrence.Perfusionist subsequently reported that the bubble alarm would not sound when tested under expected alarm conditions.We deem failure to detect gross emboli a reportable occurence.
Additional Manufacturer Narrative
Physical testing of the returned sap cable found no damage and functioned as intended.The logs were reviewed and found a communication issue between the centrifugal pump and the system.It was determined that the fault was most likely to be a loose connection between the pump and the frame, via the sap cable, due to improper seating of the cable at the time of the event.

• Brand Name: QUANTUM WORK STATION
• Common Device Name: BLOOD GAS MONITOR
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: edward blogg ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 20599820
• Report Number: 3006073153-2024-00082
• Device Sequence Number: 20465011
• Product Code: DRY
• UDI-Device Identifier: 05060434422309
• UDI-Public: 05060434422309
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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: QWS12E
• Device Catalogue Number: 51-000094-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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