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Model Number NOT APPLICABLE |
Device Problems
Occlusion Within Device (1423); Device Displays Incorrect Message (2591)
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Patient Problems
High Blood Pressure/ Hypertension (1908); Toxicity (2333)
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Event Type
Injury
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Manufacturer Narrative
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The system was used for treatment.The instrument's serial number was not provided in the article; therefore, the device history review could not be conducted.Trends were reviewed for complaint categories, equipment performance, hypertension, and other adverse event: citrate toxicity.No trends were detected for these complaint categories.From a device perspective: as it is unknown why these patients required blood products, the device cannot be ruled out as a contributing factor in this event.This case will be reported as an mdr out of an abundance of caution.Since this event is associated with the treatment, this mdr will be against the instrument.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: hypertension and toxicity (citrate).(b)(4).Device not returned to manufacturer.
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Event Description
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In an article written by kapadi et al., pediatr blood cancer 2015;62:1485-1488, an institutional review board study was performed on patients being treated for graft versus host disease (gvhd) using extracorporeal photopheresis (ecp).The study took place from september 2010 to may 2014.The article reported that seven treatments were terminated early secondary to patient hemodynamic instability, line occlusions, or alarms (the actual alarms were not specified in the article).The article stated that technical complications, including line occlusions requiring tissue plasminogen activator (tpa) and instrumental alarms, occurred 30 times during this study period.The article reported that there were two hypertensive episodes in patients undergoing ecp treatments during this study.The article also stated that there were 27 incidents where blood products were required and one incident of citrate toxicity.The article did not specify if these events occurred before or after drug administration or even what drug was used during the study.No other information regarding these patients was provided in the article.The instrument was not returned for investigation.
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Search Alerts/Recalls
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