Catalog Number IAP-0500 |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/28/2016 |
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 the clinical engineer is calling to discuss the appropriate way to check out a pump that was removed from service earlier.The clinical engineer (ce) stated that on set up, they had a purge failure (3) alarm message (he has the strip), switched out the pump and the second pump was fine.Therapy was delivered with minimal delay.The clinical engineer (ce) wants to make sure that this pump is ok to return to service.The clinical support specialist first verified that nothing was connected to the pump, and she had the clinical engineer (ce) power up, and then press pump status on.A purge failure (3) alarm occurred.The css explained that this is the appropriate response for the pump and we discussed the alarm message and possible causes.The clinical engineer (ce) had mixed messages as to what point in the process this alarm occurred.The clinical service specialist (css) discussed possible scenarios and stressed this is why it is important that they call during the event as information is lost or forgotten afterward.The clinical service specialist (css) then walked the clinical engineer (ce) through connecting the balloon in tube, putting the pump in operator and internal trigger and returning to pump status on.The pump pumped with no difficulty completing the purge cycle appropriately.The clinical engineer (ce) is going to run the pump for a while and initiate pumping and purging a few times before returning the pump to service.At 1404- additional call direct to the clinical service specialist (css) cellphone.The clinical engineer (ce) received additional different information and was now told that initially they had a "large helium leak" alarm that transitioned to a purge failure.(no large helium leak strip available) the clinical service specialist (css) discussed with the clinical engineer (ce) that these are two separate alarms and it sounds like they didn't have the catheter connected to the pump or at the quick connect when the attempted to start pumping we discussed both alarms at length.There is confusion as to what order the alarms occurred as well.There was no blood in the tubing and the same catheter that was in used with the second pump (no reported catheter issue).The clinical service specialist (css) and clinical engineer (ce) discussed other possible scenarios and that these are all hypothetical without detailed correct information.Based on our conversation, and that the clinical engineer (ce) ran the pump for "some time" with several restarts and purges and was unable to recreate any issues, the pump was returned to service.The clinical engineer (ce) feels that this was likely a "user error" and that there is some confusion with what happened initially.A lot of people and chaos involved.The clinical service specialist (css) reminded the clinical engineer (ce) to tell them that they can call the clinical service specialist (css) directly if they have additional questions and to call the hotline next time so we can help them.The clinical service specialist (css) also told the clinical engineer (ce) that she will be there in two weeks and will follow up with in-servicing.The clinical service specialist (css) told the clinical engineer (ce) that she would also speak to the field service agent to make sure that what the clinical engineer (ce) did to check the pump was good and we didn't miss anything.The clinical service specialist (css) spoke directly to the field service agent (fsa) who agreed with the clinical engineer's (ce) assessment and returning the pump to service.The clinical service specialist (css) and clinical engineer (ce) didn't miss anything.
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Manufacturer Narrative
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(b)(4).Evaluation: teleflex could not perform a full evaluation on this complaint as no parts or recorder strips were returned.As reported via hospital clinical engineer no problems were found with the pump.The pump functioned as designed.The root cause of this problem is unknown.Teleflex will continue to monitor for similar reports of this issue.
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Event Description
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It was reported via a hot line call the clinical engineer is calling to discuss the appropriate way to check out a pump that was removed from service earlier.The clinical engineer (ce) stated that on set up, they had a purge failure (3) alarm message (he has the strip), switched out the pump and the second pump was fine.Therapy was delivered with minimal delay.The clinical engineer (ce) wants to make sure that this pump is ok to return to service.The clinical support specialist first verified that nothing was connected to the pump, and she had the clinical engineer (ce) power up, and then press pump status on.A purge failure (3) alarm occurred.The css explained that this is the appropriate response for the pump and we discussed the alarm message and possible causes.The clinical engineer (ce) had mixed messages as to what point in the process this alarm occurred.The clinical service specialist (css) discussed possible scenarios and stressed this is why it is important that they call during the event as information is lost or forgotten afterward.The clinical service specialist (css) then walked the clinical engineer (ce) through connecting the balloon in tube, putting the pump in operator and internal trigger and returning to pump status on.The pump pumped with no difficulty completing the purge cycle appropriately.The clinical engineer (ce) is going to run the pump for a while and initiate pumping and purging a few times before returning the pump to service.@ 1404- additional call direct to the clinical service specialist (css) cellphone.The clinical engineer (ce) received additional different information and was now told that initially they had a "large helium leak" alarm that transitioned to a purge failure.(no large helium leak strip available) the clinical service specialist (css) discussed with the clinical engineer (ce) that these are two separate alarms and it sounds like they didn't have the catheter connected to the pump or at the quick connect when the attempted to start pumping we discussed both alarms at length.There is confusion as to what order the alarms occurred as well.There was no blood in the tubing and the same catheter that was in used with the second pump (no reported catheter issue).The clinical service specialist (css) and clinical engineer (ce) discussed other possible scenarios and that these are all hypothetical without detailed correct information.Based on our conversation, and that the clinical engineer (ce) ran the pump for "some time" with several restarts and purges and was unable to recreate any issues, the pump was returned to service.The clinical engineer (ce) feels that this was likely a "user error" and that there is some confusion with what happened initially.A lot of people and chaos involved.The clinical service specialist (css) reminded the clinical engineer (ce) to tell them that they can call the clinical service specialist (css) directly if they have additional questions and to call the hotline next time so we can help them.The clinical service specialist (css) also told the clinical engineer (ce) that she will be there in two weeks and will follow up with in-servicing.The clinical service specialist (css) told the clinical engineer (ce) that she would also speak to the field service agent to make sure that what the clinical engineer (ce) did to check the pump was good and we didn't miss anything.The clinical service specialist (css) spoke directly to the field service agent (fsa) who agreed with the clinical engineer's (ce) assessment and returning the pump to service.The clinical service specialist (css) and clinical engineer (ce) didn't miss anything.
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Search Alerts/Recalls
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