Model Number 2420-0007 |
Device Problem
Reflux within Device (1522)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: primary bag; secondary bag, therapy date: (b)(6) 2018.The customer's report of a potassium infusion emptying sooner than expected could not be confirmed.Although requested, the suspect set has not been received.A review of the pcu event log shows that potassium chloride central 40meq/250ml was programmed to infuse at a rate of 62.5ml/hr with a vtbi of 250ml at 10:54 am on (b)(6) 2018.At 10:55 am, the user changed the vtbi to 270ml and the rate to 67.5ml/hr.At 11:32 am, the infusion was paused.At 11:34 am, the user channeled the device off.The volume recorded as being infused during this period was 41.536ml.A follow up report will be submitted with failure investigation results should the primary set be received for evaluation.
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Event Description
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The customer reported that a secondary infusion of potassium chloride 250ml was programmed to infuse over 4 hours; however, approximately 40 minutes later the nurse found the potassium bag empty.Biomed examined the iv bag and tubing set and found that they were properly set up, and the pump settings were found to be correct.Biomed tested the pump at the same settings and found that it infused at the correct volume and rate.The customer later reported that the patient required additional lab work which demonstrated that the patient's potassium level decreased instead of increasing, indicating that the patient did not receive the full dose of medication.A check valve failure is suspected to have occurred causing backflow from the secondary to the primary bag.There was no lasting harm caused to the patient.
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Manufacturer Narrative
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The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
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Event Description
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The customer reported that a secondary infusion of potassium chloride 40meq/sodium chloride 0.9% 250ml was programmed to infuse over 4 hours; however, approximately 40 minutes later the nurse found the potassium bag empty.Biomed examined the iv bag and tubing set and found that they were properly set up, and the pump settings were found to be correct.Biomed tested the pump at the same settings and found that it infused at the correct volume and rate.The customer later reported that the patient required additional lab work which demonstrated that the patient's potassium level decreased instead of increasing, indicating that the patient did not receive the full dose of medication.A check valve failure is suspected to have occurred causing backflow from the secondary to the primary bag.There was no lasting harm caused to the patient.
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Event Description
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The customer reported that a secondary infusion of potassium chloride 40meq/sodium chloride 0.9% 250ml was programmed to infuse over 4 hours; however, approximately 40 minutes later the nurse found the potassium bag empty.Biomed examined the iv bag and tubing set and found that they were properly set up, and the pump settings were found to be correct.Biomed tested the pump at the same settings and found that it infused at the correct volume and rate.The customer later reported that the patient required additional lab work which demonstrated that the patient's potassium level decreased instead of increasing, indicating that the patient did not receive the full dose of medication.A check valve failure is suspected to have occurred causing backflow from the secondary to the primary bag.There was no lasting harm caused to the patient.
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Manufacturer Narrative
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The customer¿s report of backflow from the secondary into the primary was not confirmed.Visual inspection of the set did not reveal any discernible signs of damage or abnormalities.Functional and pressure testing resulted in no leaking or backflow.The root cause of the customer¿s report of suspected backflow was not identified.
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Search Alerts/Recalls
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