Catalog Number 5000-01-01 |
Device Problems
Device Inoperable (1663); Defective Component (2292)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Event Description
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It was reported that during completion of the service record investigation for this device, a faulty mixing pump was found.
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Manufacturer Narrative
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The reported issue of the unit not cooling was confirmed with a functional capacity test.The root cause was isolated to a mixing pump issue; as the circulation pump controls filling/flow.Flow was fine.The tech stated once the parts (pumps) were replaced the unit was retested and cooled to set temperatures.Pump will be replaced during preventative maintenance (pm).Pm was performed.Per the pm procedure; pumps, heater and drain ports were replaced.The device was cleaned and an electrical safety test was performed and passed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.1018233-2018-01882-1.
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Event Description
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It was reported that during completion of the service record investigation for this device, a faulty mixing pump was found.
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Search Alerts/Recalls
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