MAUDE Adverse Event Report: SARANAS, INC. EARLY BIRD BLEED MONITORING SYSTEM; INTRAVASCULAR BLEED MONITOR

Model Number	FG001-01
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A bleed in the contralateral retroperitoneal space did not trigger a level 1 bleed indication in the early bird device.A product experience report was created to document this case as an inquiry only by the interventionist.The interventionist did not initially provide any data regarding the case or patient as his interest was in the bioimpedance signal as it related to this contralateral bleed.This event did not trigger a complaint; the early bird device is not intended to detect contralateral bleeds.While intervention was required as a result of the procedure, the early bird device did not cause or contribute to the injury.The patient is ok.After mdr 3016011241-2022-00001 was submitted to the fda due to customer feedback, and after discussions with physicians at the same hospital, it was decided, out of an abundance of caution, to document this as a retrospective mdr.
Additional Manufacturer Narrative
Based on the investigation and data collected, it was determined that the ebbms did not cause or contribute to death, serious injury or illness for this event.The ebbms device functioned as intended as evidenced by the plot of the impedance signal.Related report number: 3016011241-2022-00001.

• Brand Name: EARLY BIRD BLEED MONITORING SYSTEM
• Common Device Name: INTRAVASCULAR BLEED MONITOR
• Manufacturer (Section D): SARANAS, INC.; 2450 holcombe boulevard; suite x; houston TX 77021
• Manufacturer (Section G): SARANAS, INC.; 2450 holcombe boulevard; suite x; houston TX 77021
• Manufacturer Contact: odell roberts ; 2450 holcombe boulevard; suite x; houston, TX 77021 ; 2817014416
• MDR Report Key: 16441212
• Report Number: 3016011241-2023-00002
• Device Sequence Number: 14240637
• Product Code: QFJ
• UDI-Device Identifier: 00866532000402
• UDI-Public: (01)00866532000402(17)211221(10)511110A
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: DEN180021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2022
• Device Model Number: FG001-01
• Device Lot Number: 511110A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown