Catalog Number IAB-05840-LWS |
Device Problem
Occlusion Within Device (1423)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: for related complaint see mdr #1219856-2018-00023 and (b)(4).
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Event Description
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It was reported by the rn that she has a patient that transferred from an outside hospital with an intra-aortic balloon pump (iabp).The rn reported that the systolic and diastolic pressures were the same.They were using a fiber-optic catheter and the light bulb was green.The clinical support specialist (css) had the rn switch to transducer and level and zero the transducer.The css talked her through the calibration procedure, and the hemodynamics did not change.A cardiology fellow came to the bedside and attempted to draw back on the catheter and stated he could not get anything back.The css told him that there must be a clot on the end of the catheter and the fiber optic sensor (fos) may be covered by the clot as well.The css told the md that they could place an arterial line to use for monitoring the timing and patient.The cardiology fellow did not want to place another line and was going to call the attending md.The css explained that the clot could have started to form at insertion.The md stated the patient was stable.The iab was taken out the following day.There was no reported patient death, serious injury or patient complications.No medical intervention was required and no delay or interruption in therapy.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of central lumen occluded is not able to be confirmed.The cause of the complaint was unable to be determined due to the returned state of the device.Due to the damage, the device was unable to be functionally tested.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.This will be monitored for any developing trends.No further action required at this time.Other remarks: for related complaint see mdr #1219856-2018-00023 and (b)(4).
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Event Description
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It was reported by the rn that she has a patient that transferred from an outside hospital with an intra-aortic balloon pump (iabp).The rn reported that the systolic and diastolic pressures were the same.They were using a fiber-optic catheter and the light bulb was green.The clinical support specialist (css) had the rn switch to transducer and level and zero the transducer.The css talked her through the calibration procedure, and the hemodynamics did not change.A cardiology fellow came to the bedside and attempted to draw back on the catheter and stated he could not get anything back.The css told him that there must be a clot on the end of the catheter and the fiber optic sensor (fos) may be covered by the clot as well.The css told the md that they could place an arterial line to use for monitoring the timing and patient.The cardiology fellow did not want to place another line and was going to call the attending md.The css explained that the clot could have started to form at insertion.The md stated the patient was stable.The iab was taken out the following day.There was no reported patient death, serious injury or patient complications.No medical intervention was required and no delay or interruption in therapy.
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Search Alerts/Recalls
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