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It was reported that the healthcare professional performed cannulation using hls cannulaes one 17fr/15cm and one 21fr/55cm to apply ecmo to a patient who needed va ecmo application, and venous cannula.The product was inserted into the venous blood vessel, but the symptoms of continuous bending occurred.The customer applied ecmo using terumo's cannulae.Complaint #: (b)(4).
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It was reported that the healthcare professional performed cannulation using hls cannulaes one 17fr/15cm and one 21fr/55cm to apply ecmo to a patient who needed va ecmo application, and venous cannula.The product was inserted into the venous blood vessel, but the symptoms of continuous bending occurred.The customer applied ecmo using terumo's cannulae.No harm or death to any person was reported.This complaint concerns the issue reported for product hls cannulae 17fr/15cm.The cannula used for the patient with infection issues.Therefore, it was discarded at the site.The photograph of the affected cannula set was provided by the customer.There was no visible evidence of damage to the hls arterial cannulae 17 fr/15 cm based on the photograph provided by the customer.At this time no similar complaint investigated was found which could led to the confirmation of the failure and / or a product related malfunction.Getinge medical affairs performed a medical assessment as follows: "the functional requirement of ecmo cannulation is to provide the ¿least traumatic¿ and most durable and simplified method for infusion and drainage of blood to the extracorporeal circuit.The hls cannulae design is optimized to include a soft and pliable structure that reduces vascular trauma/erosion during long-term support and application.Detailed knowledge of patient anatomy and vascular pathophysiology are necessary to avoid or address the challenges that may present during cannulation.A variety of approaches can be used for cannulation that include percutaneous seldinger technique, open cut-down, open cut-down seldinger (¿semi seldinger¿) or open cut-down with end-to-side graft (dacron) to the artery¿.The approach used is the responsibility of the attending physician, and is based on the experience, training, preference and clinical need of the patient.Each technique has advantages and disadvantages that are reported in the literature that are beyond the scope of this assessment.Getinge recommends the seldinger technique with strict adherence to warnings and cautions given the expertise necessary to avoid and/or address technical and clinical complications.¿in general, percutaneous cannulations should be accomplished with seldinger¿s technique.Patient related factors are to be assessed and are ultimately at the discretion of the attending physician.Long and smooth guide wires are forwarded, if possible under echocardiographic or fluoroscopic control.The access can be stepwise widened with appropriate dilators before advancing the cannula.An ultrasound estimation of the vessel size is recommended to avoid mismatches.Vascular calcifications and previous vascular surgery may render cannulation difficult or even impossible.Alternative strategies are then needed, which include targeting another vessel or open surgical cannulation (possibly suturing a dacron tube)¿.The following possible root causes are suggested from the reference above: the correspondence does not indicate whether cannulation was performed using imaging techniques.Imaging techniques such as ultrasound guidance, fluoroscopy and echocardiography are recommended clinical adjuncts to detect scarring, and vascular anomalies that can significantly complicate cannulation.A frequently reported root cause has been associated with insufficient dilatation of the insertion site.Insufficient dilation can result in very high resistance when attempting to advance the cannulae.High resistance has been reported to result in cannulae damage due to bending.Accurate vessel sizing is recommended by using ultrasound techniques mentioned above.Bending of the cannulae has also been associated with incorrect sizing of the cannulae for the target vessel.Further possible root causes are mentioned by rupprecht et al.: the inability to insert cannulas into the appropriate vessels has the consequence that extracorporeal support is not possible.Main underlying reasons are responsible for cannulation [difficulty]: morbidly obese patients, resuscitation scenarios, and severe vascular calcifications or scarring.A number of patient related root causes have been reported by rupprecht et al based on frequency of occurrence.¿the inability to insert cannulas into the appropriate vessels has the consequence that extracorporeal support is not possible.Main underlying reasons are responsible for cannulation [difficulty]: morbidly obese patients, resuscitation scenarios, and severe vascular calcifications or scarring¿.Technique related root causes cited in the literature include: an inappropriate steep angle of cannulation can result in a complicated cannulation and high resistance.Pre-wetting the cannulae in saline is important to reduce resistance; however, a solution that is too warm can render the cannulae too flexible and promote bending during advancement.Mal-position of the introducer and kinking the cannulae during insertion.Without the advantage of direct product testing, a more definitive root cause of the observed bending/damage to the cannulas cannot be provided in this medical assessment.However, given the available information, and the many possible root causes that can result in cannulae bending/damage, there is no definitive association that this observed event was associated with a manufacturing defect, or device mal-performance.In summary mishandling during preparation and insertion can result in damage to the cannulae and the wire re-enforcement.High resistance during insertion due to patient related factors or technical factors can damage the cannulae.The review cannot determine whether this event was associated with a use error although it may be one of the root causes as identified above." the production history record (dhr) of the affected be-pas 1715# with lot#3000230233 was reviewed.According to the dhr results, the product be-pas 1715# passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.Further the incoming inspection reports of the affected component "701046339 fem body17_as-01#peri.Cath.Body 17fr," were reviewed on 2022-12-14.The cannula body was checked for ridges, sharp edges, cracks and streaks visually.All tests were passed as per specifications.Based on the information above, the product problem could not confirmed.The cause of the event could not be traced to device but could be related to user interaction and patient conditions that makes it difficult the use of cannulae.The occurrence rate was calculated for the reported failure and product 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.
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