86-Series

Description of Event or Problem

Getinge became aware that, during routine use of the washer disinfector, the detergent delivery tubing became disconnected from the injection port, resulting in the washer operating without enzymatic detergent for an estimated period from approximately 06:00 on (b)(6) 2026, until 14:05 on (b)(6) 2026. Because the disconnection occurred downstream of the flow monitoring system, no alarm was generated. Wash loads processed during the affected period were routinely evaluated using wash verification indicators, and the indicators reportedly met their acceptance criteria. The processed loads were subsequently sterilized following completion of the wash cycles. The detergent dosing problem was identified only after personnel observed detergent pooling on the floor near equipment. Some instruments from affected loads were reportedly used in patient procedures. Additional report is being submitted to comply with the requirement of one report per potentially exposed individual. As a precautionary measure, potentially affected patients were placed on broad-spectrum antiviral and antibiotic therapy. No injuries or infections have been reported. The detergent delivery issue was corrected by the hospital's maintenance personnel, and the washer was returned to normal operation.It has been additionally reported on July 24th 2026 that by far currently suspected number of patients affected is 2. Additional report is being submitted to comply with the requirement of one report per potentially exposed individual.

Additional Manufacturer Narrative

No UDI is available for the affected device with catalog number S-8666913-CTOM, since UDI was not required when the device was manufactured in 2014.Additional information will be provided following the conclusion of the investigation. This is second report related to this incident, which was originally reported under 9616031-2026-0000011.