Catalog Number 5C4471R |
Device Problem
Noise, Audible (3273)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/08/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been received and the evaluation is in progress.Upon completion of the investigation, or if any additional relevant information is received, a supplemental report will be submitted.
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Event Description
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It was reported that a homechoice device emitted a sparking noise.This was noted during prime of peritoneal dialysis.The patient stated that they could not see any visible signs of sparking but the deice was making a noise that sounded like a wire sparking.The technical services representative (tsr) arranged a swap and discussed the use of manual supplies to complete therapy until the new device arrives.There was no patient injury or medical intervention reported.No additional information is available.
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Manufacturer Narrative
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(b)(4).The homechoice device was returned to baxter healthcare for evaluation.A service history review was performed and did not reveal any previous service events that could have caused or contributed to the reported problem.An external and internal visual inspection revealed no issues.The device was tested and passed the return instrument test/evaluation (rite) electrical test and functional test.A simulated therapy was performed.During priming, the device made a loud sparking sound.The reported condition was verified.The cause of the issue was determined to be a noisy compressor.The device was sent to service with instructions to rework the compressor.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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