Customer called getinge for assistance with a patient on a cs300 intra aortic balloon pump (iabp) with a getinge fiber optic intra-aortic balloon (iab) in place.
There was a full code situation going on with loss of optical sensor and ecg signal and the iabp displayed "optical sensor failure" during cardiopulmonary resuscitation (cpr) and it was believed that there was a possible break of the fiber optic catheter due to cpr.
The clinicians attempted to establish blood pressure signal via central lumen but they were having trouble finding the cable.
The patient was revived but with poor ecg activity still present.
The getinge representative instructed the nurse to switch to semi-auto and attempt to find a lead that could be seen.
Weak signal was established in avr (augmented vector right) but not strong enough for the iabp to pick-up r waves.
Customer finally found the cable and hooked up the transducer, but the patient was coding again.
After zeroing, they were able to get a pressure signal from cpr effort and the iabp began assisting during code.
The getinge representative called back after one hour and was advised that a patient code was called.
The getting representative discussed some issues with the customer such as making sure they had cables on each iabp for pressure transducer.
The patient died from an unknown underlying disease, and the patient death is not attributed to the iabp.
The date of the death is unknown.
Refer to mfg report number 2248146-2018-00364 for balloon catheter information.
Please note that there was an error with transposition of information involving this and another complaint (mfg report number 2249723-2018-00892), which resulted in the patient coding being incorrectly captured and reported under the afore-referenced report number.
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