Patient underload.Fresenius kabi received a complaint for a quantity of (b)(4) as the customer reviewed 1 device and did not inspect the other 9 that they received.The entire quantity on hand was listed in the complaint.No sample or pictures were received for evaluation.Per the initial customer report, the 1 reviewed device had impaired glueing of one of the pump segments - it is mounted in reverse.Not all kits have this defect, it occurs at random.No patient injury has been reported.Fresenius kabi received 2 pictures from the customer.Within the pictures, the connection exchange of the system tubing to the pump tubing of the transparent pump adapter is clearly visible.Fresenius kabi investigation: potential hazard / hazardous situation: tube glued into wrong port of the pump adapter, potential harm: patient underload, severity of the harm: catastrophic, occurrence of the harm: improbable.Fresenius kabi's investigation not this is an isolated finding.Describe assignable cause: assembly failure.Fresenius kabi corrective/preventive action: an assembly tool has been implemented with the transparent pump adapter, to exclude a connection exchange.This was implemented 02 jul 2019.This complaint is on a batch after the change.This will be monitored in production process and an awareness training has been given.
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