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It was reported that the pressure drop of the quadrox-id has steadily increased during patient treatment.The clinicians believe that in the oxygenator was build thrombosis.The treatment of the patient was discontinued.No harm to any person has been reported.The affected product was requested for further investigation but the customer already scrapped the product.Therefore a technical investigation could not be performed at the getinge laboratory.Thus, the exact root cause could not be determined.A medical assessment was performed by getinge medical affairs team on 2023-05-16 with the following conclusion: a complaint cluster was reported by this account (with reference to complaints (b)(4)).All the quadrox id oxygenators were scrapped by the customer except the one associated with complaint (b)(4).All the questionnaires related to these events, except complaint (b)(4) are outstanding.As a result, an assessment of the reported trend will be evaluated in a subsequent update of this interim report when further information is procured from the clinic and customer.Based on the provided data and investigation results of the similar complaint (b)(4) a hemolytic mechanism is the suggested as the possible root cause.The pre-conditions that may cause this event have been identified with the quadrox id pediatric oxygenator and rotaflow combination with an estimated occurrence of 1:5000 cases under the following conditions: (quadrox id pediatric_screw_usermanual_g-306_1.6.1_06 nonus subsection 5.2 safety instructions for extracorporeal circulation, 2022).In isolated cases (< 1:5000) the use of the quadrox-id pediatric with the rotaflow centrifugal pump (rf-32), can result in increased blood damage in the sense of mechanically-induced hemolysis if the following conditions coincide: use of shunt lines.Hydrodynamically undesirable loading of the centrifugal pump, e.G., in cases of low blood flows and relatively high speeds and/or the use of tube clamps.Presence of a hematocrit value in the serum at the high end of the normal range.This manifests itself in a rising pressure gradient above the oxygenator due to increased deposits of erythrocyte fragments on the blood inlet side of the oxygenator.Simply exchanging the oxygenator without simultaneous optimization of the extracorporeal circulation with reduced shear stress can result in the blood damage described above reoccurring.If the conditions described above apply, the hemolysis parameters and transmembrane pressure must be checked thoroughly for all patients.Due to severe hemodynamic loads, cell debris such as erythrocyte fragments may enter the tube circuit during applications with a centrifugal pump.This can lead to an increase in the transmembrane pressure at the oxygenator, hemodynamic instability, hemolysis, inflammation, and inadequate patient support.This combination can result in rising transmembrane pressure gradients as a result ¿pump-induced hemolysis¿, and the accumulation of red cell stroma deposits on the blood inlet side of the membrane.A smaller membrane (pediatric vs adult quadrox id) for this patient application would likely reduce or eliminate significant shunt fractions.Further, a review of the interactions of the spectrum medical centrifugal pump and the oxygenator may prove helpful.The above possible root cause (pump-induced hemolysis) may not be the only plausible reason for complaint (b)(4) or the ¿trend¿ reported at this clinical site.Further information (questionnaires and investigation reports) is necessary for each of the five subsequent complaints to establish a possible association.The following are possible but not limited to the following root causes.Red blood cell (rbc) agglutination.Select studies and white papers have shown that certain drugs may induce immune hemolytic anemia (diiha).(chen & zhan, 2014) (garratty, 2010).Shredding of existing clot by the centrifugal pump with subsequent deposition on the prechamber from packed rbcs administered to the patients.Because packed rbcs have a defined lifespan, older banked blood may be prone to liberate the byproducts of cell aging.(liumbrun & aubuchon, 2010), (vermeer, et al., 2022) platelet transfusion in close association with the observed event (chegondi, vijayakumar, badheka, & karam, 2022), (hazboun, et al., 2021).That said in light of the reported trend for multiple similar events, it is unlikely the above variables were present for all cases.The most likely root cause appears to be ¿pump induced hemolysis due to hydro-dynamic loading¿ as identified in the warning statement in the ifu of the quadrox id pediatric.The following statement from the complaint bears mentioning: ¿post pump (pre oxygenator) pressure has steadily been increasing at a much higher rate than this account has experienced historically.¿ effective date: (b)(6) 2022; revision: 03.Because the spectrum medical centrifugal pump (cp-22) has a newer market release than other centrifugal pumps in the market, it may be of value to identify which centrifugal pump was used by the customer prior to the spectrum medical cp-22.That said, questions arise regarding the historic natural of the observation.1.How did post pump pressures change with the change in equipment? 2.Was a change to the extracorporeal circuit made to accommodate the cp 22? 3.Could such a change circuitry have been influential in producing the circumstances detailed by the customer? in summary, the investigation report suggests this event was unrelated to a device (viz.Oxygenator) malfunction or mal-performance.A centrifugal pump malfunction and/or pump-induced hemolysis cannot be ruled out based on a review of the available information.The assessment of centrifugal pump performance lies with the legal manufacturer.In this case, a closer review of the ¿new¿ spectrum medical cp 22 may be recommended.The event was not associated with patient harm according to the correspondence.Further, a use error or patient related factors cannot be ruled out.The questionnaire that remain outstanding will be evaluated and appended to this interim report when available.Thus, at this time a confirmation of the failure "pressure dropped, decrease of performance" was not possible.Most probable the reported event was not caused or associated with a product related malfunction.The exact root cause of the reported event remains unknown.The production records of the affected beq-hmod70000-usa #squadrox-id ad.O.Fil.With packaging lot# 3000203321 were reviewed on 2023-05-25 for the reported failure.According to the final test results, all beq-hmod70000-usa #squadrox-id ad.O.Fil.With lot# 3000203321 passed the test as per specifications.Production related influences are unlikely.The customer will be informed about the investigation results by a getinge sales and service representative.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.H3 other text : 4115.
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