Status:
Ready to upload
Record number:
1659
Adverse Occurrence type:
MPHO Type:
Estimated frequency:
Rare, however, understanding the frequency of operator error as identified in this report is, in part, reliant upon voluntary reporting of such an adverse event to the MAUDE (Manufacturer and user facility device experience) data base in the USA, or using a similar reporting mechanism in other countries. The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and by voluntary reporters such as health care professionals, patients and consumers.
Time to detection:
Immediately; a high pressure system alarm error occurred, a 'pop' was heard, and autologous blood began to leak/spray immediately into the open chamber surrounding the centrifuge bowl.
Alerting signals, symptoms, evidence of occurrence:
A 10-year-old boy (44 kg, 3520 mL total blood volume) with chronic graft-versus-host disease after allogeneic stem cell transplant was undergoing extracorporeal photopheresis using the Cellex instrument. After 150 mL of whole blood was processed, the instrument alarmed due to a tubing leak and the procedure was aborted. Blood in the tubing and in the centrifuge bowl was not returned to the patient due to the loss of sterility from the leak. The estimated blood loss was approximately 200 to 300 mL. There was not a recognizable adverse reaction because the patient’s preprocedure hematocrit was 27.2% and the following day it was 28.4%. He had stable vital signs before (blood pressure 135/72, pulse 103 bpm, temperature 36.4°C) and after (blood pressure 127/72, pulse 112 bpm, temperature 36.1°C) the incident and did not result in the need for a transfusion.
Demonstration of imputability or root cause:
An investigation by Therakos, the manufacturer of the centrifuge bowl/tubing kit, showed no machine or procedural kit malfunctions. Examination of the drive tube, however, revealed wear marks on the outside of the drive tube near the upper bearing stop that were consistent with a misload. Wear of the upper bearing likely occurred because the bearing stop was moving while touching something fixed. Since 2010, there are at least five reports to Therakos or to the FDA of a drive tube leak using the Cellex. Possible reasons for blood leakage into the centrifuge chamber may include a defective drive tube (i.e., certain lots) or centrifuge bowl misload by the end-user. When installing the centrifuge bowl, it is important to verify that the bearings and drive tube are not damaged and the drive tube bearings are fully seated in their retainer clips.
Groups audience:
References:
Suggest new keywords:
autologous, blood, misload, user error
Reference attachment:
Suggest references:
M. Paroder-Belenitsky, Y. C. Tanhehco. Extracorporeal photopheresis drive tube leak due to end-user misload. Transfusion 2015;55;1829
Expert comments for publication:
Loss of 200-300 mLs of an autologous donation due to end user misload of the centrifuge bowl/tubing kit. There is a potential for contamination of returned blood if situation not immediately addressed.