Model Number 10120 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Tachycardia (2095); Chills (2191); Reaction (2414)
|
Event Date 12/30/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Investigation: the run data file (rdf) was analyzed for this event.No definitive root cause for the reported adverse events could be identified from the rdf and there were no issues during the procedure.The following alarms occurred during procedure: 3x return pressure was too high when system was diverting saline, 3x return pressure was too high, 1x inlet pressure was too low.Access alarms alone are not known to cause adverse events but the excessive occurrence of them points toward issues with the patient access.The constant alarming of the device combined with frequent manipulation of the access may have caused increased agitation in the patient and resulted in the adverse event for some of these procedures.The most common source of inlet pressure alarms is when the inlet flow rate is set too high for the given patient access, the patient access is occluded/blocked, or the patient access is not properly positioned.In response to inlet pressure alarms, it is suggested to ensure the patient access is appropriately sized and positioned, nothing is blocking the access line, and to lower the inlet flow rate.Throughout the procedure the ac was returned at 0.9ml/min/ltbv to the patient.No other potential sources of a patient reaction were identified.The system operated as intended and the procedures were run within standard operating limits (i.E.Not in ¿caution status¿).Investigation is in process.A follow-up report will be provided.
|
|
Event Description
|
The customer reported that an autologous patient with non-hodgkin's lymphoma experienced a reaction during a collection procedure.The patient presented chills, nausea, restlessness, headache, biliary vomit, hyperthermia (temperature increase from 37 to 40 degrees celsius in <10 minutes), and tachycardia of 131 beats per minute (starting pulse rate was 90bpm).There were no signs of muscle spasms, chevostek signs, signs of trousseau, tetany, arrhythmia, seizure, tingling sensation, or paresthesias.Two ampules with 1 gram each of calcium gluconate were administered.Hydrocortisone was also administered.Patient identifier, age and outcome are not available at this time.The disposable set is not available for return because it was discarded by the customer.
|
|
Manufacturer Narrative
|
This report is being filed to provide additional information in h.6 and h.10.Investigation: a disposable search history was performed for this lot.There were 2 other similarly reported incidents on this lot from the same customer in the same incident month.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the patient reaction as experienced by the customer.Investigation is in process.A follow up report will be provided.
|
|
Manufacturer Narrative
|
This report is being filed to provide additional information in b.5, h.6, and h.10.Root cause: no definitive root cause for the reported adverse event could be identified from the dlog associated with this procedure.The system operated as intended and the procedures were run within standard operating limits (i.E.Not in ¿caution status¿).The procedure on (b)(6) had 1 ¿inlet pressure was too low¿ alarm and 6 ¿return pressure was too high¿ alarms.513ml of ac was delivered to the patient over the course of the procedure.Access alarms alone are not known to cause adverse events but the excessive occurrence of them points toward issues with the patient access.The constant alarming of the device combined with frequent manipulation of the access may have caused increased agitation in the patient and resulted in the adverse event for this procedure.The most common source of inlet pressure alarms is when the inlet flow rate is set too high for the given patient access, the patient access is occluded/blocked, or the patient access is not properly positioned.In response to inlet pressure alarms, it is suggested to ensure the patient access is appropriately sized and positioned, nothing is blocking the access line, and to lower the inlet flow rate.Throughout the procedure the ac was returned at 0.9ml/min/ltbv to the patient during the mnc procedure.No other potential sources of a patient reaction were identified.In summary, a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged citrate reaction include but are not limited to patient disease state and/or patient sensitivity to anticoagulant.
|
|
Event Description
|
Patient identifier, age, and outcome are not available from the customer.
|
|
Manufacturer Narrative
|
This report is being filed to provide additional information in h.10.Investigation: according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated with apheresis is ususally well tolerated.Symptoms often show as parasethesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.Investigation is in process.A follow up report will be provided.
|
|
Search Alerts/Recalls
|
|