Fresenius continuous autotransfusion system (cats) unit stopped working at beginning of use, was not able to finish a cycle.After initiating use, the unit displayed a "blood in" and "blood flow" error.Unit was removed from service and brought to clinical engineering for inspection.Manufacturer was called in and after troubleshooting the unit found a problem with the at3 autotransfusion set.The manufacturer's engineer found the set tubing that goes to the htc sensor not long enough (a possible manufacturing error) to allow the sensor to reach its proper placement in the cat unit, having the user to pull on the tubing in order to make it reach.While the user pulled on the tubing, inadvertently decreased the tubing internal size, preventing the blood to flow through it, thus causing the system error and stopping operation.The at3 part number is (b)(4) and the lot number is fit 063.A new at3 from a different lot was used to test the cat unit and the system worked fine, according to manufacturer's specifications.Manufacturer response for at3 continuous autotransfusion set, at3 autotrasfusion set (per site reporter).Manufacturer field engineer checked unit and concluded problem was caused by the at3 set (lot # fit 063) not being manufactured correctly.
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