Model Number 0684-00-0470-01 |
Device Problems
Off-Label Use (1494); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Complete event site name: university of (b)(6) hospital.Complete initial reporter name: (b)(6).Additional reporter name: (b)(6) 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, the console generated three gas loss alarms within 10 minutes.The insertion was reported to be axillary, which is not the method described in the device instructions for use.There was no blood in the helium tubing and no visible kinks before the insertion site.The customer also reported that the console indicated a catheter restriction several times.The console was pumping alarm-free at the time of the call.The customer was advised to do use the "iab fill" key and/or drop the augmentation level.It was later reported via follow-up call that the patient has had three axillary iabs inserted as they are awaiting heart and kidney transplant.The patient was very mobile.During the call, the customer had to attend to them several times to have them get back in bed.The customer was again made aware of the off-label use and advised they would be troubleshooting from a femoral approach.The positional nature of the alarms was reviewed, it was verified that there was no blood in helium tubing, and connections secure on every occasion.The 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 oct-19 through sep-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).
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Manufacturer Narrative
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Changed device available for eval from yes to no.Additional contact person information (b)(6).The device will not be returned to the manufacturer so we are unable to complete an evaluation.If additional information is provided we will send a supplemental report with the additional information.Complaint record id # (b)(4).
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Search Alerts/Recalls
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