MAUDE Adverse Event Report: SYNAPSE CARDIOVASCULAR; SYNAPSE CV

Model Number	N/A
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: unknown.The issue was evaluated and replicated in the fmsu lab; the cause was traced to a software configuration.This issue is very rare and requires many tries with large studies to reproduce; it is considered to be a very rare occurrence in a clinical environment.The numeric id assigned to a patient record could be reused once a newer patient record was merged to an older patient record.When this action is done, the newer id is made available again.This was not an issue prior to advanced reporting.With the introduction of advanced reporting the numeric id is not released within the advanced reporting database schema and that is how the mismatch between the patient demographic data can occur.Ref: internal complaint number comp (b)(4).
Event or Problem Description
On december 02, 2020 fujifilm medical systems u.S.A., inc.(fmsu) service department received a customer inquiry for assistance with synapse cardiovascular.Study was sent in for a new patient with the correct mrn.Incorrect mrn is showing in cv client.On december 16, 2020, a risk assessment was performed to investigate the risk to patient safety.There was no patient impact, serious injury, or death associated with this event.The issue is considered highly detectable by a healthcare professional.
Additional Manufacturer Narrative
Fujifilm initiated a recall on (b)(6) 2021 to alert customers of the patient id issues existing in synapse cv 6 users with advanced reporting.Fujifilm submitted c&r report (1000513161-05/05/2021-001-c) to the fda, which was classified as class ii and assigned recall number z-1775-2021 on 06/02/2021.No further investigation is necessary.

• Brand Name: SYNAPSE CARDIOVASCULAR
• Common Device Name: SYNAPSE CV
• MDR Report Key: 11159001
• Report Number: 3004972322-2021-00001
• Device Sequence Number: 3489085
• Product Code: LLZ
• UDI-Device Identifier: 00854904006015
• UDI-Public: (01)00854904006015(10)0602100
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K151859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 06/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2019
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: SEE H10
• Patient Sequence Number: 1