MAUDE Adverse Event Report: Rochal Technologies LLC BIASURGE® Advanced Surgical Solution; Irrigation Solution

Model Number	BAS-0101
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, biasurge advanced surgical irrigation solution was used at the end of an abdominal procedure for a large ventral hernia repair at ochsner medical center.The patient was a 37 year-old female without significant co-morbidities.Biasurge was used as a warmed fluid instilled after decanted to the large surgical surface area superficial to the peritoneal cavity.The patient developed a significant rash after use of biasurge and became hypotensive and tachycardic.Medical intervention included administration of benadryl and steroids, after which the patient's condition returned to baseline over four hours without any permanent effects.
Additional Manufacturer Narrative
An investigation was completed; based on the information documented in the batch record, the batch complies with product specifications and meets the requirements for final release.Based on the number of units distributed to date and the reported incidents, the estimated potential incident rate is (b)(4).Monitoring activities will continue to assess any emerging trends, additional reporting, or other actions.

• Brand Name: BIASURGE® Advanced Surgical Solution
• Common Device Name: Irrigation Solution
• Manufacturer (Section D): Rochal Technologies LLC; 12000 network blvd; suite b200; san antonio TX 78249
• Manufacturer (Section G): LABORATORIOS PISA S.A. DE C.V.; carretera a san isidro mazatep; tlajomulco de zuniga, jalisco 45640 ; MX 45640
• Manufacturer Contact: william coulston ; 12000 network blvd; suite b200; san antonio, TX 78249 ; +1(210)375-9349
• MDR Report Key: 50944876
• Report Number: 3021784063-2026-00001
• Device Sequence Number: 16065158
• Product Code: FRO
• UDI-Device Identifier: 00850017274006
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K223377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 Model Number: BAS-0101
• Device Lot Number: Q2503009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 1 LB
• Patient Race: White