| Catalog Number 10220 |
| Device Problems
Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Hemorrhage/Bleeding (1888)
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| Event Date 03/28/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Investigation is in process.A follow-up report will be provided.
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Event Description
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The customer reported that an auto red blood cell exchange (rbcx) patient with priapism was discharged home after his procedure.Per the customer, they used five bags of 500ml normal saline during the procedure, when they normally use one.He was later admitted to the hospital after developing some complications.He had bleeding in the ventricles.He remained in hospital and required a blood transfusion.The patient suffered loss of memory and unconsciousness three days after the procedure.A ct scan (brain) suggested intraventricular hemorage.Surgery was done by a neurosurgeon.Per the customer, the patient is "doing better now".The disposable set is not available for return as it was discarded by the customer.
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Manufacturer Narrative
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Investigation: a disposable history search concluded there were no similar occurrences reported on this lot worldwide.Investigation is in process.A follow up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide additional information in b.6 and h.10 and corrected information in h.1.Investigation : the run data file (rdf) was analyzed for this event.Review of the run data file did not show any unusual signals or events for the reported ¿excessive use of normal saline¿ during the rbcx procedure.The aim images were not available for review as the operator disabled the aim system prior to the start of the run due to the ¿aim system failed channel imaging test¿ alarms.As the aim system was disabled, the images cannot confirm if the inlet saline line was opened instead of the access line clamp to the patient at the start of the run.According to the reported complaint, 5¿500ml bags of normal saline were given to the patient during the 84-minute procedure.It is unknown at this time as to why the reported saline volume was administered to the patient during the procedure.Review of the rbcx procedure confirmed that the procedure was completed successfully attaining the end target values as detailed in the run summary.Investigation is in process.A follow up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.10.Investigation: the device history report was reviewed for this lot.There were no issues noted that would have contributed to the suspected hypervolemia as experienced by the customer.Investigation is in process.A follow up repport will be provided.
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Manufacturer Narrative
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Investigation: according to the dlog, the final configured fb was 125% and the patient's tbv was 5234ml.The unintended saline bolus was calculated to be 2500ml (based on the use of 5x500ml saline bags) which results in a worst-case unintended fb of +73%.The procedural cautions section of the spectra optia apheresis system essentials guide, pg 11, states that if the roller clamp on the saline line is left completely open when the patient is connected, the patient will be quickly infused with a large volume of saline.Investigation is in process.A follow up report will be provided.
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Event Description
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Per the customer, the 500ml of saline was an unintended bolus.The customer declined to provide patient identifier.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.10.Updated investigation: the run data file was analyzed for this event.Review of the run data file did not show any unusual signals or alarms during the rbcx procedure for the reported ¿excessive use of normal saline¿ complaint.According to the complaint description, 5¿500ml bags of normal saline were given to the patient during the 84-minute procedure.After priming of the disposable set is complete, the system no longer uses saline and the operator is instructed to confirm that both the inlet and return saline lines are closed prior to connecting the patient lines and starting the procedure.Analysis did confirm that shortly after the run was started, an additional ¿confirm saline lines were closed¿ alarm was generated after the pumps had been paused for 3 minutes due to the delay in confirming the ¿predicted fluid balance exceeded¿ alarm.Based on the complaint description, one way that excess saline could enter the system is if the operator left the inlet line saline roller clamp open at the start of the run.The aim images could be used to possibly confirm if the inlet saline roller clamp was left open however the operator disabled the aim system prior to the start of the run.The aim system was disabled after the ¿aim system failed channel imaging test¿ alarm was generated twice at the start of prime.This aim alarm can occur when the automated process control (apc) reports that one of the post-start-up tests failed.Possible causes include channel not loaded correctly in the centrifuge filler, dirt was on the covers of the aim system lights, disposable connector or the filler, or debris on the aim camera window or on the optical reference block in the centrifuge.The alarm screen instructions state to touch the stop button and open the centrifuge door to confirm that the channel is loaded correctly in the filler and verify the aim components are not impeded by dirt or debris.Analysis did not show that the centrifuge door was opened at any time during the run.Review of the run data file confirmed that the rbcx procedure was completed successfully attaining the end target values as detailed in the above run summary.Investigation is in process.A follow up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide additional information in b.6 and h.10.Investigation: after multiple follow-up attempts, the customer did not provide additional proceudral details for this event.The operator stated that they thought that they needed to run saline through spectra optia during the entire rbcx procedure.During the procedure, saline was wrongly given to the patient through the saline line.The saline line clamp was left open.The operator couldn't remember if the saline was given through the inlet or return line.Saline was given continuously over a period of time during the procedure.The physician was unable to determine the cause of the patient developing haemorrhage.An internal health hazard evaluation was initiated.Although severity related to hypervolemia indicates death/serious injury, this hhe concludes that there is improbable risk of operator error running saline through entire procedure resulting in serious injury or medical intervention.This isolated incident indicates that use of spectra optia is not likely to cause adverse health consequences related to this type of potential operator error.Investigation is in process.A follow up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.10.Correction: terumo bct offered customer retraining for this issue.The regional sales consultant confirmed that the retraining was completed on may 21st, 2021 investigation is in process.A follow up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.10.Investigation: the customer provided a hematologist report confirming the patient's diagnosis of sickle cell disease (scd) with history of priapism.According to the nursing report, "patient is a known scd with previous history of priapism.He walked into the unit for ebt red blood cell exchange done with aid of optia apheresis machine.He was canulated via femoral artery catheter insertion.Done with lindocaine la.His vital signs before procedure are t 36.8, p68, r20, bp 121/52, spo2, 94% wt 74 kg, ht 183 cm.During the procedure: he had about 6 units of blood and normal saline over 4000 ml infused procedure lasted for 80 minutes and was successful, no reaction until about 4 minutes to the end of the procedure when he had some reactions of calcium depletion and probably fluid over load.He had tremors, temperature spike of up to 39 degree centrigrade.The following intervensions were carried out as prescribed by dr.Chikadibeh.Tab calcium sandox effervescent tablet added to water.Peak milk given orally.Injections pcm 900mg lasix 40mg hydrocort 200mg pentazocine 30mg all the above was given via femoral catheter.The following vital sign was observed 5:00pm bp 172/90 after 5min 169/91 spo2,98% hr 91 rr24 temp 38.9 6pm bp 149/72 hr 80 rr 24 temp 38.9 spo2 94% 6:20pm bp122/61 pr (b)(4) rr20cpm tem38.6 spo2 93% 7:30pm bp106/49 spo2 94% temp 39.0 then suppository diclofenac 100mg was inserted immediately.8:30pm bp 121/60 hr 72 rr24 spo2,94%temp 36.5 10:00pm bp 118/64 hr83 tem36.6 rr22 spo2,94% 10:30pm bleeding from femoral cannular site, which was removed shortly after pressure dressing was applied.It was mildly soaked with blood of about 2-3ml.The dressing was changed and patient was reassured, he was observed for further bleeding.Nil bleeding observed.Patient was awake until 12mn then i encouraged him to sleep.He slept till 3;50am when he woke up.Vital signs 4am bp 113/58 pr72 t36.6 rr24 spo2,94% nb he had his prescribed drugs at 10pm coartem 80/480,pcm 1g 12mn he made adequate volume of urine during the shift about 3 time over the night.6:45am bp 108/47 temp 36.1 spo2 96% p76 rr 22 patient was discharged home in a stable condition with the following vital signs temp-37.5 pulse -78 bp-105/53 spo2-95% rr-20 anti malaria and diclofenac supp given.The customer provided patient's blood work details before the procedure on (b)(6) and on (b)(6) days later when the patient was admitted for medical intervention.In order to ascertain the effectiveness of the procedure, multiple attempts were made to obtain the patient's blood work and hemoglobin s status post procedure.The customer did not respond to our requests for further details.On (b)(6) 2020 04:52:37 pm pre exchange blood work details s-calcium(total) 2.1 mmol/l white cell count 10.7 x 10^9/l absolute neutrophil count(ne) 6.2 x 10^9/l absolute lymphocyte count(ly) 3.4 x 10^9/l absolute monocyte count(mo) 0.2 x 10^9/l absolute eosinophil count(eo) 0.7 x 10^9/l normal absolute basophil count(ba) 0.2 x 10^9/l neutrophil(ne) 57.8 % lymphocyte(ly) 31.6 % monocytes(mo) 2.1 % eosinophil(eo) 6.5 % basophil(ba) 2.0 % red blood cell red blood count ** 1.97 x 10^12/l haemoglobin(hgb) ** 6.2 g/l hct(pcv) ** 19.2 % mcv 97.5 fl mch 31.5 pg mchc 323 g/l rdw-cv 26.1 %cv rdw-sd 102 fl platelet platelet(plt) 294 x 10^3/ul pct 0.2% mpv ** 6.7 fl pdw ** 18.5% hemoglobin variant analysis,blood.Hemoglobin a **9.52% hemoglobin a2 **3.98% hemoglobin f **3.53% hemoglobin s **82.97% (b)(6) 2020 07:57:19 am post exchange blood work details: white cell count 6.2 x 10^9/l absolute neutrophil count(ne) 3 x 10^9/l absolute lymphocyte count(ly) 2.5 x 10^9/l absolute monocyte count(mo) 0.2 x 10^9/l absolute eosinophil count(eo) 0.4 x 10^9/l normal absolute basophil count(ba) 0.2 x 10^9/l neutrophil(ne) 48.2 % lymphocyte(ly) 40.1 % monocytes(mo) 2.4 % eosinophil(eo) 6.7 % basophil(ba) **2.6 % red blood cell red blood count ** 3.3 10^12/l haemoglobin(hgb) ** 8.8 g/l hct(pcv) ** 28.3 % mcv 85.5 fl mch 28.3 pg mchc **286 g/l rdw-cv 22.1 %cv rdw-sd 75.6 fl platelet platelet(plt) 271 10^3/ul pct 0.18% mpv ** 6.7 fl pdw ** 18.5% the aim system is not used to control the interface position in rbcx procedures.Aims is only used to detect high interface positions as part of spillover detection (along with the rbc detector).In this case, the operator had disabled the aim system due to the ¿aim system failed channel imaging test¿ alarms.As a result, we were unable to utilize aims images to confirm the position of the interface.We were also unable to confirm if the saline was administered via inlet saline line or return saline line.The patient's tbv was 5234 ml,hematocrit was 19.2% and hemoglobin s was 83% prior to the procedure.If 5 bags of saline were given via the inlet saline line, the saline would have diluted the incoming patient's blood, lowered the channel hematocrit, leading to failure of the machine to establish an interface.This would have resulted in less defective rbcs removed from the patient, hence, a less effective exchange procedure as targeted.If the saline bolus was administered via the return saline line, the patient's hematocrit would have decreased incrementally and caused the interface position to shift lower over the course of the procedure.In addition, the saline flow would also impede the return flow resulting in less replacement rbcs being returned to the patient.Both would have resulted in a less effective exchange procedure.Based on the final fluid balance (125%) and the extra saline bolus administered throughout the procedure, there is evidence of fluid overload.Investigation is in process.A follow up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.10.Investigation: terumo bct distributor field service coordinator confirmed that the problem was due to aim subsystem failure.During troubleshooting the post start up test was failing, and they were unable to lock the reference block at the right position.Zero position was adjusted until and the reference block was at the right position.The post start up test passed after the adjustments.Auto test and saline run were performed and all passed.Machine performs to manufacturer's specifications.Investigation is in process.A follow up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.10.Root cause: based on the dlog, complaint investigation, and operator's statements, the root cause for the operator's confusion about the use of saline during the entire procedure was a result of inadequate training and limited experience.A definitive root cause for the subsequent patient reaction and intraventricular hemorrhagecould not be determined.Possible causes include but are not limited to: - patient's pre-existing medical condition - fluid overload and/or ineffective therapy as a result of excessive infusion of saline solution during rbcx procedure.
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Search Alerts/Recalls
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