The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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The customer states that a cardiac patient had a triple lumen umbilical vessel catheter and after placement, multiple fluid boluses and drops were ordered.The providers requested the bedside nurse hand push boluses instead of running them on a pump.The nurses had a hard time pushing the meds because there was a lot of resistance.It was discovered that there was a crack in the tertiary lumen after the echo tech felt the fluid from the boluses splashing him.The neonatal nurse practitioner was notified, and replaced the triple lumen umbilical vessel catheter with another.
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