Catalog Number IAP-0500 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/01/2016 |
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 via a hot line call from the registered nurse in the icu, calling to troubleshoot a system error 7 alarm.The iab-05840-lws was inserted approximately 4 hours ago and the pump had been pumping well since in the unit.They then got the system error 7 alarm.The buttons on the screen were all flashing at one point then the screen was black.The clinical support specialist had the rn try to disconnect and reconnect the umbilical cable at the head and the pump by the tank with no change in status.The css also had them attempt a power reset with no change.The css recommended they exchange the pump.The pump was changed to an autocat (only other available pump).At 2234 - follow up: the patient now supported on the autocat, only a few minutes delay in therapy during the exchange.Pump is pumping well with no alarms and achieving the goals of therapy.At 0213 est- direct call- the sales rep brought in his pump and they have started using it.The css walked them through performing a map cal on the new pump.The pump is pumping well without alarms.Prior to the switch, they attempted to connect the head from the sales rep's pump to their pump and it worked so the problem has been isolated to the head.The pump has been pulled to send to biomed.At0754- follow up call to the rn, the pump is pumping well and achieving the goals of therapy.The rn asked that the css have the field service follow up with biomed regarding the pump.Additional information was received on 06/20/2016 via the field service report (b)(4).Symptom: system 7 error.Findings / action taken: found and replaced defective display head assy and label.Could not make fos fail but replaced fos connector any way.Everything checks out ok.Fcn level: 2.24, software level: 2.24.Expedited qa review: yes.Op = on patient.Confirmed.
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Manufacturer Narrative
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(b)(4) the display head assembly (p/n 77-3016-001w, s/n (b)(4)) was returned for evaluation.Visual inspection of the display head assembly was performed and no obvious damage or defects were noted.The display head assembly was installed onto a known good autocat2w and functional testing was performed.The display head assembly in question failed functional testing.The pump alarmed system error 7 approximately 10 seconds after power-up.The assist ratio left button was noted to be stuck while pressing however, the button was release and functioned normal after pressed.The pump was then operated as normal after reset the alarm.The display head then in question passed functional testing.Every button on the display head were pressed multiple times (wait for 10 seconds on each press) when the pump was powered; and no alarms or errors were occurred.The pump was then left to run for over 6 hours with no alarms or errors.Also, shook the display head while the pump was pumping with no alarms or distortion observed.Visual inspection of the display head assembly internal hardware was performed and no other abnormalities were found.All connectors were proper seated.See other remarks section.Other remarks: 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.Conclusion: the reported complaint of "alarm, system error 7" is confirmed.The reported problem was reproduced during the functional test.The pump alarmed system error 7 approximately 10 seconds after power-up.The assist ratio left button was noted to be stuck and that caused the reported problem.The cause of the sticky button is undetermined.
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Event Description
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It was reported via a hot line call from the registered nurse in the icu, calling to troubleshoot a system error 7 alarm.The iab-05840-lws was inserted approximately 4 hours ago and the pump had been pumping well since in the unit.They then got the system error 7 alarm.The buttons on the screen were all flashing at one point then the screen was black.The clinical support specialist had the rn try to disconnect and reconnect the umbilical cable at the head and the pump by the tank with no change in status.The css also had them attempt a power reset with no change.The css recommended they exchange the pump.The pump was changed to an autocat (only other available pump).At 2234 - follow up: the patient now supported on the autocat, only a few minutes delay in therapy during the exchange.Pump is pumping well with no alarms and achieving the goals of therapy.At 0213 est- direct call- the sales rep brought in his pump and they have started using it.The css walked them through performing a map cal on the new pump.The pump is pumping well without alarms.Prior to the switch, they attempted to connect the head from the sales rep's pump to their pump and it worked so the problem has been isolated to the head.The pump has been pulled to send to biomed.At 0754- follow up call to the rn, the pump is pumping well and achieving the goals of therapy.The rn asked that the css have the field service follow up with biomed regarding the pump.Additional information was received on 06/20/2016 via the field service report (b)(4) symptom: system 7 error findings / action taken: found and replaced defective display head assy & label.Could not make fos fail but replaced fos connector any way.Everything checks out ok.Fcn level: 2.24, software level: 2.24.Expedited qa review: yes.Op = on patient.Confirmed.
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Search Alerts/Recalls
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