MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. QUANTUM PUMP CONSOLE; HEART LUNG MACHINE

Catalog Number	52-000001-00
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Field safety correction will be issued.No change to the risk profile was required.Standard risk control is to hand crank pump if there is a pump stoppage.The software is on the quantum workstation and has been updated 13th june 2019.The update contains software that updates firmware to any connected accessory (device) e.G.Pump console power unit, roller pumps.(b)(4).
Event or Problem Description
Spectrum medical ltd received an incident report on 24th may 2019 that the quantum pump console shut down on (b)(6) 2019 during tetralogy of fallot open heart surgery.Hand crank of the pump was used to maintain patient support, operation completed successfully.No injury to the patient.The perfusion system identifier from (b)(6) for this particular hlm was identified via the system monitor, qws (b)(4).Summary of the assessment: the software team reviewed the incident report and the diagnostic logs and have identified that incorrect data was queried from the battery firmware leading to power loss to the accessory ports on the hlm.It was determined that the corrective action is a software update that will fix the vulnerability that created this malfunction of the power supply.This same issue was identified in mdr-001 report.A field safety correction will be issued.

• Brand Name: QUANTUM PUMP CONSOLE
• Common Device Name: HEART LUNG MACHINE
• Manufacturer (Section D): SPECTRUM MEDICAL LTD.; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• MDR Report Key: 8797026
• Report Number: 3006073153-2019-00002
• Device Sequence Number: 18912281
• Product Code: DTQ
• UDI-Device Identifier: 05060434420008
• UDI-Public: 05060434420008
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: K173834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2019

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 Catalogue Number: 52-000001-00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 YR
• Patient Weight: 15