DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0684-00-0576-01 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/19/2022 |
Event Type
Death
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Manufacturer Narrative
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Additional initial reporter name & occupation - (b)(6), icu rn.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.Complaint record id # (b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy blood was seen within the helium tubing.The customer was advised to stop therapy immediately and call the physician to remove the balloon within 30 minutes due to risk of thrombus.Upon follow up on (b)(6) 2022 at 8:44am, it was discovered that the physician ordered the staff to continue running the iab despite the instructions for use (ifu) stating to stop therapy and remove the iab.At 11:15am, received word from the local team that the physician elected not to remove the iab due to risk of thrombosis.Due to the patient¿s clinical condition, the team felt he would not tolerate being under anesthesia for a vascular procedure thus the iab was not removed.The patient was put on comfort care.At 1:43pm, received word from the local team that the patient expired with the iab in place as it was unable to be removed safely.
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Event Description
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N/a.
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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.Reference complaint#: (b)(4).
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