MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM CENTRIFUGAL DRIVE; CENTRIFUGAL PUMP

Model Number	QCD22
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Approximately 2 hours after initiation of ecmo, the cp22 became dislodged from the drive unit.Ecmo flows were stable without issue prior to the occurrence.The disposable was immediately inspected for cracks, air, compromise.Nothing seen upon visual inspection.The cp22 was placed back in the drive unit, but did not seem to be spinning correctly and a "strange sound" was heard at the pump head (not grinding).The primer elected to change out the cp22 emergently per center protocols.The patient was supported by the medical team during the intervention and required pressor support with 1 additional dose of epinephrine.Total time off bypass was 11 minutes.Ecmo flow was restored following the pump head change out.No further issue with the pump head/drive unit was noted throughout the duration of the ecmo run.

• Brand Name: QUANTUM CENTRIFUGAL DRIVE
• Common Device Name: CENTRIFUGAL PUMP
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LIMITED; 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: 19002374
• Report Number: 3006073153-2024-00002
• Device Sequence Number: 18499121
• Product Code: DWA
• UDI-Device Identifier: 05060434421821
• UDI-Public: 05060434421821
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K192838
• 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): 03/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: QCD22
• Device Catalogue Number: 51-000061-00
• 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: 02/13/2024
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: QUANTUM CENTRIFUGAL BLOOD PUMP (CP22V-VT)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown