Model Number IPN001112 |
Device Problems
Pumping Stopped (1503); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/16/2020 |
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 by a clinical support specialist (css) that the pump had a system error 7 sub code 16 and stopped pumping during an in service.The iab volume was reading 0 and 0%.When the 100% full volume was touched it still remained at 0.The css touched the full volume and apply, and the pump completed a purge cycle and the screen displayed the correct volume.There was no patient involvement.
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Event Description
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It was reported by a clinical support specialist (css) that the pump had a system error 7 sub code 16 and stopped pumping during an in service.The iab volume was reading 0 and 0%.When the 100% full volume was touched it still remained at 0.The css touched the full volume and apply, and the pump completed a purge cycle and the screen displayed the correct volume.There was no patient involvement.
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Manufacturer Narrative
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Qn#(b)(4).Teleflex did not receive the device for investigation.The reported complaint of system error 7 and screen restarts is confirmed by a teleflex field service engineer and the photos submitted with the complaint.A teleflex field service engineer was able to duplicate the screen reset issue when the display brightness keys are rapidly pressed.The root cause of this complaint is software related.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.A non-conformance has been initiated to further investigate the issue.
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Manufacturer Narrative
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Qn#(b)(4).Please note: a correction is being made to the result code and conclusion code and therefore the follow-up is being resubmitted.Teleflex did not receive the device for investigation.The reported complaint of system error 7 and screen restarts is confirmed by a teleflex field service engineer and the photos submitted with the complaint.A teleflex field service engineer was able to duplicate the screen reset issue when the display brightness keys are rapidly pressed.The root cause of this complaint is software related.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.A non-conformance has been initiated to further investigate the issue.
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Event Description
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It was reported by a clinical support specialist (css) that the pump had a system error 7 sub code 16 and stopped pumping during an in service.The iab volume was reading 0 and 0%.When the 100% full volume was touched it still remained at 0.The css touched the full volume and apply, and the pump completed a purge cycle and the screen displayed the correct volume.There was no patient involvement.
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Search Alerts/Recalls
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