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

Model Number QCD22

Device Problem Insufficient Information (3190)

Event Date 02/09/2024

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 338880548
• Report Number: 3006073153-2024-00002
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 05060434421821
• UDI-Public: 05060434421821
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2021
• 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
• Treatment: QUANTUM CENTRIFUGAL BLOOD PUMP (CP22V-VT)
• Patient Outcome(s): Required Intervention