Model Number 0684-00-0576-01 |
Device Problem
Calibration Problem (2890)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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, the console generated a fiber optic sensor failure alarm.Troubleshooting was completed but unsuccessful.It was noted that the patient¿s mean arterial pressure (map) was in the 80s.The customer was assisted in changing over to the fluid lumen, however, the line was clotted.They did attempt to aspirate with no blood return.They were then advised to cap this line ¿no access¿ and discuss plan with physician as the patient did not have an alternate arterial source.There was no patient harm or adverse event reported.
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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.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period sep-19 through aug-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint # (b)(4).
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Search Alerts/Recalls
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