​Teleflex—Arrow AutoCAT2 and AC3 Optimus Intra-Aortic Balloon Pumps: Component May Be Susceptible to Vibration Failure, Potentially Resulting in Alarms and Abrupt Cessation of Function or Inability to Start

June 3, 2020 | Risk Management News

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In a May 20, 2020, Urgent Medical Device Correction letter submitted by ECRI member hospitals, Teleflex states that a component (motor connector) in the above IABPs may be susceptible to vibration failure, resulting in fretting, charring, and discoloration of the motor connector wires. Teleflex also states that this may result in pump alarms for "System Error 3" and "High Baseline" being presented on the screen of the IABP and potential abrupt cessation of function or inability to start the IABP. Teleflex further states that the occurrence of this problem is related to aging of the component. Teleflex states that it has received no reports of a sudden stoppage without a prior "System Error 3" or "High Baseline" alarm indicative of deterioration of the component; however, the absence of prior alarms does not ensure that the IABP is not affected by this problem. Teleflex also states that if a patient requires circulatory support with an IABP and the device does not work, or if...

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