| Model Number 10120 |
| Device Problems
Backflow (1064); Use of Device Problem (1670); Device Displays Incorrect Message (2591)
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| Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 06/16/2020 |
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Event Type
malfunction
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Manufacturer Narrative
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Lot number and expiry are not available at this time.Investigation: per the customer, it is unknown how much fluid was given by the machine.Total amount of fluids delivered by other method: ac in plasma: 32ml ac in collect: 9ml ac to patient 344ml total fluid removed/collected: 80ml collect bag, 291ml plasma estimated volume of saline given to patient: 700ml calculated final fluid balance: 656ml the customer returned one used optia set for investigation containing blood.Visual inspection confirmed the set was assembled correctly with no kinks, leaks or missing parts.The saline, ac and collect bag lines were rf sealed.The ac, saline and collect bags were not returned for investigation.It was not possible to identify the kit lot number or to accurately estimate the volume of saline administered during the run.Flow of blood was verified throughout the inlet/return coil, cassette fluid pathway, loop, channel assembly and return reservoir with no occlusions found.The inlet and return saline line roller clamps were present on the correct lines, but the roller wheels to occlude the lines were not fully engaged.The saline lines were flow tested in this position; under pressure from a fluid filled syringe, saline was unable to advance through the partially closed clamp.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 during a mononuclear cell (mnc) collection procedure on a patient with hodgkin's lymphoma, the machine was alarming and indicating the inlet saline not closed, when it was.Per the customer, the cassette emptied itself and got foam in it.They could not rinse back when the procedure was ended.Per the customer, the set seemed to be letting fluid back to patient through the inlet line.The customer reported that the patient is ok.No injury occurred, and no medical intervention was required.Patient identifier is not available at this time.
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Manufacturer Narrative
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Investigation: the run data file was reviewed for this event.Signals in the rdf and images suggest an obstruction in the inlet line led to the alarms generated and subsequent early termination of procedure.Review of the dlog associated with this complaint confirms the occurrence of excessive ¿inlet pressure was too low¿ alarms.Inlet pressure alarms started shortly after onset of the run and persisted for the duration.The most common source of pressure alarms is when the inlet flow rate is set too high for the given patient access or the patient access is not properly positioned.In response to these alarms, it is suggested to check the positioning of the patient access and lower the inlet flow rate.Later on, during the procedure there were ¿inlet pressure sensor malfunctioned¿ and ¿low-level reservoir sensor did not detect fluid¿ alarms.If the inlet line or inlet line trap develops an obstruction or partial occlusion from a skin plug or clot, this can cause the malfunction of the inlet pressure sensor and explain these alarms.In addition, a development of a clot in this location may cause the inlet line to stop drawing entirely, or to draw less fluid into the system because it is blocking the fluid pathway.This in turn can cause less fluid to exit the channel via the passive rbc line and can result in the reservoir alarms previously mentioned because less fluid is being returned to the reservoir than the system expects.Since these alarms occurred later in the procedure, it is suspected that clumps from the patient¿s access site were pulled into the inlet line later during the run.The procedure had multiple extended pauses during the run which could also lead to clotting.The patient access to the inlet manifold is not coagulated and can clot off if the system is paused for an extended period of time.Additionally, the 4 ¿inlet line was not clamped¿ alarms were likely caused by the clotting in the inlet line and inlet trap and therefore the system could not see the pressure change that was expected and therefore was unable to continue into rinseback.Investigation is in process.A follow up report will be provided.
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Event Description
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The customer declined to provide patient identifier due to eu data protection laws.
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Manufacturer Narrative
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This report is being filed to provide additional information in b.6, h.6, and h10.Corrected information is provided in h.3.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.According to the dlog, the final configured fluid balance (fb) was 103% and the patient's tbv was 4981ml.The unintended saline volume was calculated to be 700ml which results in a worst-case unintended fb of +17%, within safety limits for fb.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.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 h6 & h10.Investigation: according to the run data file analysis, the hct entered was 34%, the tbv was 4981 ml and final fluid balance was 103%.Final fluid balance (fb) with 700 ml unintended saline bolus: fb = (1.03 x 4981 ml) + 700 ml/4981 x 100 = 117 % root cause: based on evidence from the returned part investigation and the run data file analysis, it is likely that the inlet saline roller clamp was left partially open when the operator was trying to troubleshoot the issues with the patient¿s inlet access.The operator should maintain a slow saline drip since the inlet line before the 3 to 1 manifold is not anticoagulated, but has forgotten to fully close the inlet saline line after troubleshooting, which resulted in the unintended saline volume.A definitive root cause for platelet clumping and aggregation could not be determined at this time.Potential causes for platelet clumping and aggregation include but are not limited to: the inlet/anti-coagulant ratios used in the procedure were inadequate to keep the extracorporeal circuit properly anti- coagulated, resulting in the activation of platelets.Activation of platelets as a result of the patient's physiology.When a dual-lumen catheter is used during calcium supplementation, there is some risk of recirculation.Calcium infused at the return site could be pumped into the extracorporeal circuit rather than to the patient.This could reverse some of the effect of the citrate anticoagulation and cause clumping in the circuit.Pausing the procedure but not the calcium infusion could cause clumping in the return line and potentially the circuit.Giving a bolus of calcium rather than a continuous infusion could also increase the likelihood of clumping in the circuit.Excessive calcium infusion in combination with a higher inlet:ac ratio could lead to clotting in the circuit.Correction: terumo bct has offered customer training for this issue.The retraining request has been accepted but has been postponed at this time due to regional restrictions related to covid-19.Retraining that was not able to be provided during covid restrictions will be monitored quarterly.
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