The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed.There were no non-conformances in the production dhr related to the reported event.A getinge field service engineer (fse) evaluated the iabp and all testing passed.It was determined that the alarm during the event was related to the augmentation settings and the patient¿s poor condition.Based on the clinical situation, and review of the event logs, the alarms seem reasonable; this was the final time in the ot as the staff was getting ready for surgery and bypass.After confirming that the iabp was operating correctly, the getinge sales representative and clinical trainer contacted the customer to offer advice in case of similar experiences in the future.No parts were replaced; therefore, no further investigation is required.
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It was reported that a competitor¿s intra-aortic balloon (iab) was inserted distally into the patient in the cath lab.During patient transport to the operating theatre (ot) while on the cs100 intra-aortic balloon pump (iabp), the patient blood pressure dropped from 110 to below 60.The patient went into a-fibrillation and crashed.The iabp began to emit an augmentation alarm.Cpr was administered to the patient and the patient was transferred to the operating theatre.It was reported that the attending perfusionist was frustrated with the alarm on the cs100, cags and arrow fiber optic balloon inserted.The patient was reportedly stable and in the icu.The customer requested that getinge evaluate the iabp due to the alarming during use.It was later suspected that the balloon was not inserted correctly and/or moved on transfer.It is suspected that the issue was due to the patient¿s condition (very unstable and very low bp) and not a pump related issue.
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