Catalog Number IAP-0400 |
Device Problems
Moisture Damage (1405); Device Inoperable (1663)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/10/2018 |
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 report by the registered nurse that during use on a patient, a heparinized saline bag exploded and the liquid spilled over the machine.This caused the pump loss of the ap waveform and eventually led to the loss of all signals.The pump did not start back up.The pump was off for approximately twenty minutes.The patient remained stable during the time.As a result the pump was switch out and replaced successfully, there was a delay in therapy to switch to another pump which caused no complications to the patient.Patient outcome: meeting goals of therapy at end of call.There were no reports of patient's complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).Teleflex did not receive the device for investigation.The reported complaint of "ap signal loss and the pump shut off" is confirmed based on the details provided from the customer.The liquid from the saline bag spilled over the pump.The cause of the reported complaint was related to a liquid spill on the pump.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.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The complaint will be monitored for any developing trends.No further action required at this time.
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Event Description
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It was report by the registered nurse that during use on a patient, a heparinized saline bag exploded and the liquid spilled over the machine.This caused the pump loss of the ap waveform and eventually led to the loss of all signals.The pump did not start back up.The pump was off for approximately twenty minutes.The patient remained stable during the time.As a result the pump was switch out and replaced successfully, there was a delay in therapy to switch to another pump which caused no complications to the patient.Patient outcome: meeting goals of therapy at end of call.There were no reports of patient's complications, serious injury or death.
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Search Alerts/Recalls
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