Model Number RI-2 |
Device Problem
Complete Loss of Power (4015)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The rapid infuser was received for evaluation on the date of this report; investigation of the device has not yet been completed.Without results of the investigation, it is difficult to determine what occurred in this case.The manufacturing records for this serial number were reviewed and nothing notable was observed.It was reported that a replacement unit was installed to continue the case.No patient injury was reported.A follow-up report will be submitted upon completion of the investigation.
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Event Description
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Belmont's distributor received a complaint from the user facility and relayed the following report: "the liver transplant surgery was scheduled on saturday, may 16th.The unit was prepared and the disposables (903-00004, 903-00006, and 903-00018) was attached and primed as usual.The unit was in operation and the surgery was going well until this problem came up.The unit had power failure and immediately shut down the system.The staffs tried to restart the system, but the power was completely gone.The staff contacted us the emergency assistance and we installed the replacement.".
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Manufacturer Narrative
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The rapid infuser was returned for investigation and was tested according to our standard operating procedures.Upon receipt, four power transistors on the driver boards were shorted and damaged, which prevented the unit from powering up.We were unable to determine the root cause of the damaged transistors.The manufacturing records for this serial number were reviewed and nothing notable was observed.A review of complaints for the past three years indicates that this was an isolated incident.There was no patient injury reported.We will continue to monitor and trend similar reports of this nature and take further corrective action if required.Should additional information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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