Aaron Adderley.
Research FDA.gov site for Biomedical Device or system Recall for the past 120 days. Report on at lease 5 devices/systems with:
1) the reason for recalls
2) the companies involved
3) how was the issue identified
4) what is the severity of the issue
5) the impact to the society if the recall was not made.
CareFusion Alaris Syringe Pump Alarm
The reason for recalls in the device is the pump causes an alarm that stops the patient’s infusion. The pump is unresponsive even if the key is pressed and the device is removed from the PC unit causing a delay of therapy. The companies involved were Carefusion 303 , Incorporated. The issue was identified when they received 108 reports of them occurring. Due to the seriousness of this case and that it can possible cause death , this is classified as a Class I. If there was not a recall on the device many people would have suffered and this device could have potentially caused deaths.
Teleflex Medical, Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube – Connector
The reason for recalls have been that the endobronchial tube’s connector may breaks or come apart causing a leakage of oxygen. Thus the patient does not receive enough oxygen and potentially go into respiratory distress which can reintubation or death. The company involved was Teleflex Medical and this …show more content…
This occurred due to the packaging interfered with the smooth side of the implant causing that side to feel rough. If the implant is placed the wrong way by mistake , blood clots form on the patch . Blood clots can lead to more detrimental conditions such as embolisms, stroke and even death may occur. This becomes a Class I recall because death is a possible factor that can occur. The company involved was Baxter HealthCare Corporation. If the recall was never made there may have been potentially fatal
Research FDA.gov site for Biomedical Device or system Recall for the past 120 days. Report on at lease 5 devices/systems with:
1) the reason for recalls
2) the companies involved
3) how was the issue identified
4) what is the severity of the issue
5) the impact to the society if the recall was not made.
CareFusion Alaris Syringe Pump Alarm
The reason for recalls in the device is the pump causes an alarm that stops the patient’s infusion. The pump is unresponsive even if the key is pressed and the device is removed from the PC unit causing a delay of therapy. The companies involved were Carefusion 303 , Incorporated. The issue was identified when they received 108 reports of them occurring. Due to the seriousness of this case and that it can possible cause death , this is classified as a Class I. If there was not a recall on the device many people would have suffered and this device could have potentially caused deaths.
Teleflex Medical, Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube – Connector
The reason for recalls have been that the endobronchial tube’s connector may breaks or come apart causing a leakage of oxygen. Thus the patient does not receive enough oxygen and potentially go into respiratory distress which can reintubation or death. The company involved was Teleflex Medical and this …show more content…
This occurred due to the packaging interfered with the smooth side of the implant causing that side to feel rough. If the implant is placed the wrong way by mistake , blood clots form on the patch . Blood clots can lead to more detrimental conditions such as embolisms, stroke and even death may occur. This becomes a Class I recall because death is a possible factor that can occur. The company involved was Baxter HealthCare Corporation. If the recall was never made there may have been potentially fatal