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Catalog Number IAP-0500 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/26/2017 |
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 by the rn who called to discuss an issue with the pump using excessive amounts of helium.They had a full tank last night, and within 4 hours half of the tank was gone, this occurred multiple times they have replaced the tank and about every 4 hours half of the tank is gone.They have checked the washer in the yoke, it was found to be intact.There is no audible loss of gas.There were no gas loss alarms or any other alarms on the pump.The connections are intact.As a result, the pump was exchanged and the new pump has not been losing gas.Patient outcome: the patient is supported on pump and achieving the goals of therapy.No complications to the patient were reported.There was no delay or interruption in therapy that caused no harm to the patient.
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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 "pump using excessive amounts of helium" is not confirmed.The pump was checked by the customer and no problem was found with the pump.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the serial and lot numbers with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint will be monitored for any developing trends.No further required at this time.
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Event Description
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It was reported by the rn who called to discuss an issue with the pump using excessive amounts of helium.They had a full tank last night, and within 4 hours half of the tank was gone, this occurred multiple times they have replaced the tank and about every 4 hours half of the tank is gone.They have checked the washer in the yoke, it was found to be intact.There is no audible loss of gas.There were no gas loss alarms or any other alarms on the pump.The connections are intact.As a result, the pump was exchanged and the new pump has not been losing gas.Patient outcome: the patient is supported on pump and achieving the goals of therapy.No complications to the patient were reported.There was no delay or interruption in therapy that caused no harm to the patient.
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Search Alerts/Recalls
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