Clot Formation in a Blood Bag during a Blood Donation Camp: A Case Report with Root Cause Analysis

Clot formation inside a collected whole blood unit is an uncommon but clinically significant event, as it implicates a deviation from standard collection practices. Any visible clot in a blood component renders the unit unsuitable for transfusion and mandates its discard, according to blood banking quality standards. During a mobile blood donation camp organised by a tertiary care institution, a well-formed clot was identified in a Packed Red Blood Cell (PRBC) unit on routine visual inspection during component preparation. The clot was a firm, red (erythrocyte-rich) thrombus occupying the upper part of the collection bag, without extension into the tubing. The unit was immediately quarantined and discarded. A structured Root Cause Analysis (RCA), comprising staff interviews, timeline reconstruction and record review, was undertaken to identify the most probable contributing factors, since an RCA identifies the most probable root cause of an event rather than establishing definitive causation. Unavailability of an automated Blood Collection Monitor (BCM) during the donation period, which necessitated manual mixing while multiple donors underwent simultaneous phlebotomy, was identified as the most probable root cause, with transient low-flow episodes during collection unable to be excluded in the absence of continuous flow monitoring. Anticoagulant defect, bag/manufacturing defect, tubing obstruction and donor-related hypercoagulability were reviewed and considered unlikely contributors. Corrective measures included retraining staff on continuous manual mixing, careful vein selection for phlebotomy, and revision of camp logistics to prioritise BCM availability at all active bleeding stations. This report highlights the vulnerability of mobile donation settings to delays in mixing and flow monitoring, and underscores the importance of structured RCA and preventive planning in resourcelimited settings.