We received one catheter as a sample still assembled inside the 24 g cannula.It is not possible to flush the catheter due to several severe occlusions.The catheter had been shortened at 2 cm.After removing the catheter from the cannula, the catheter tube was thoroughly examined microscopically but no defect could be detected.A slight fibrin formation was visible at about 9.5 cm.Cardiac tamponade is a rare complication of piccs placed in neonates.One reason for failure is the catheter tip inserted too far into the neonate's heart.This obviously happened here as well as we got informed that after detecting a cardiac arrest due tamponade, cardiac resuscitation was performed and the withdrawal of the catheter by 1 to 2 cm.Furthermore, we warn in the product's ifu: "the using physician should be familiar with and undertake all standard precautions to avoid problems or complications associated with the introduction and use of central venous catheters.Complications associated with percutaneous catheter placement include vessel wall perforation, cardiac tamponade, hemorrhage, air embolism, catheter embolism, nerve lesions, infections, thrombosis.Precautions: the catheter tip must not be advanced into the heart (right atrium).The location of the catheter within the heart may cause cardiac tamponade, or cardiac arrhythmias.It is necessary to make checks of the catheter tip position at regular intervals throughout the usage of the catheter." it seems as if the users did not do the tip position checks at regular intervals.Having checked the batch history records, no deviations were found.Each catheter is flow and leak tested during production.The tensile force and dimensions of catheter components are randomly checked.Incoming goods inspections and two 100% visual tests after packaging are carried out.This is the very first complaint for batch 040221go and we have two further complaints regarding a cardiac tamponade on code 1261.207 within the last three years.This type of defect is included in the risk analysis and its occurrence rate, and the risk evaluation is acceptable.No further corrective action initiated by quality management as there are no indications of a manufacturing fault.
|