MAUDE Adverse Event Report: STIHLER ELECTRONIC GMBH ASTOTUBE®; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Model Number	IFT40410
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a routine plasma exchange the connection (luer type) between the apheresis set and the warmer tubing set vibrated loose allowing < 100 ml of blood loss.During setup this operator ensured the connection was very tight (as this incident has happened before) and when leak was discovered it was found to be "finger tight." there was no complete separation of the lines, but enough that blood was allowed to leak out via the threaded connection.The connection was re-tightened and monitored the remainder of the procedure.Patient was stable throughout, no changes in hgb/hct noted.

• Brand Name: ASTOTUBE®
• Common Device Name: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): STIHLER ELECTRONIC GMBH; 12011 mosteller road; cincinnati OH 45241
• MDR Report Key: 19688802
• Report Number: 19688802
• Device Sequence Number: 8009478
• Product Code: BSB
• UDI-Device Identifier: 04260114140610
• UDI-Public: (01)04260114140610
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/20/2024
• Report Date (Section F): 03/20/2024

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
• Device Model Number: IFT40410
• Device Catalogue Number: IFT40410
• Device Lot Number: 32094602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/20/2024