Catalog Number IAP-0500 |
Device Problems
Unable to Obtain Readings (1516); Connection Problem (2900)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/26/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the rn called the clinical support specialist to troubleshoot a "light weight sensor (lws)".The fiber optic sensor (fos) waveform has been a flat line during all of the troubleshooting attempts.The rn was not able to switch the pump at the time of the call and therefore the central lumen was flushed and utilized.The waveform is much better and the patient support looks "great.A second call was received the following day with the same patient and same pump.The second rn called to troubleshoot "low augmentation".The css discussed with the rn the multiple factors with augmentation.During discussion, the css suggested connecting the fos to another console.The rn was able to connect the fos to a second pump.The rn received a waveform as expected and they were able to calibrate the fiber optic sensor and the icon is white.The patient continued to receive therapy.There was no reported death or complications to the patient.A delay in therapy while exchanging the pump but no harm to the patient was caused.Patient outcome: the patient remained stable.
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Manufacturer Narrative
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Qn# (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "fos not recognized" is not able to be confirmed.The pump was checked by the hospital biomed and the problem could not be reproduced.The root cause of the reported complaint is undetermined.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.This complaint will be monitored for any developing trends.
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Event Description
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It was reported that the rn called the clinical support specialist to troubleshoot a "light weight sensor (lws)".The fiber optic sensor (fos) waveform has been a flat line during all of the troubleshooting attempts.The rn was not able to switch the pump at the time of the call and therefore the central lumen was flushed and utilized.The waveform is much better and the patient support looks "great.A second call was received the following day with the same patient and same pump.The second rn called to troubleshoot "low augmentation".The css discussed with the rn the multiple factors with augmentation.During discussion, the css suggested connecting the fos to another console.The rn was able to connect the fos to a second pump.The rn received a waveform as expected and they were able to calibrate the fiber optic sensor and the icon is white.The patient continued to receive therapy.There was no reported death or complications to the patient.A delay in therapy while exchanging the pump but no harm to the patient was caused.Patient outcome: the patient remained stable.
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Search Alerts/Recalls
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