MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM CENTRIFUGE DRIVE - CP22; CARDIOPULMONARY BYPASS PUMP SPEED CONTROL

Model Number QCD22

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2022

Event Type  malfunction  

Manufacturer Narrative

Pump communication error.Pump replaced.

Event Description

Communication issue of cp22 motor driver.The cp22 driver and cable was replaced and eliminated the issue.The patient was not affected by this incident.

• Brand Name: QUANTUM CENTRIFUGE DRIVE - CP22
• Type of Device: CARDIOPULMONARY BYPASS PUMP SPEED CONTROL
• 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: 15986505
• MDR Text Key: 305510902
• Report Number: 3006073153-2022-00004
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 05060434421838
• UDI-Public: 5060434421838
• 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: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2022
• 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