DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Myocardial Infarction (1969); Cardiogenic Shock (2262)
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Event Date 02/05/2021 |
Event Type
Death
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Manufacturer Narrative
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Event site postal code - (b)(6).Initial reporter name - (b)(6) additional initial reporter information - (b)(6).The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (b)(4).
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Event Description
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It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) alarmed.When the clinical user selected "help" a "unit overheating" message appeared.The intra-aortic balloon pump (iabp) was swapped for another to finish the procedure.Patient had expired due to poor prognosis.Immediate cause of death: cardiogenic shock.Antecedent causes: myocardial infarction.The patient went into cardiogenic shock, arrested, ventricular fibrillation (vf), defibrillated, pulseless electrical activity (pea) and cardiopulmonary resuscitation (cpr) x 10 minutes.A separate report will be submitted for the cardiosave intra-aortic balloon pump (iabp).
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Manufacturer Narrative
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The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.The device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.The review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.The overall 24 month product complaint trend data for the period (b)(6) 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews were performed to obtain all possible information.Complaint record id # (b)(4).H3 other text: device not returned.
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Event Description
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It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) alarmed.When the clinical user selected "help" a "unit overheating" message appeared.The intra-aortic balloon pump (iabp) was swapped for another to finish the procedure.Patient had expired due to poor prognosis.Immediate cause of death: cardiogenic shock.Antecedent causes: myocardial infarction.The patient went into cardiogenic shock, arrested, ventricular fibrillation (vf), defibrillated, pulseless electrical activity (pea) and cardiopulmonary resuscitation (cpr) x 10 minutes.A separate report will be submitted for the cardiosave intra-aortic balloon pump (iabp).
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