Model Number LIBERTY |
Device Problems
Air Leak (1008); Fluid/Blood Leak (1250); Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device had not been returned to the manufacturer.A supplemental report shall be filed if the device is received.
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Event Description
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The patient contact reported that during the patient's previous night's treatment the cycler displayed m31 air detected in cassette.The patient was on a drain.The contact stated they ended the treatment.When the cycler door was opened to remove the cassette, it was noted that fluid was leaking.The cycler will be replaced.Tech support advised discontinuing use of the cycler.The has manual supplies and will confer with clinic regarding the next night's treatment.
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Manufacturer Narrative
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For 2937457-2017-00624 as follows: date of report: 09/06/2017.Date received by manufacturer: 08/10/2017.
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Event Description
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The patient contact reported that during the patient's previous night's treatment the cycler displayed m31 air detected in cassette.The patient was on a drain.The contact stated they ended the treatment.When the cycler door was opened to remove the cassette, it was noted that fluid was leaking.The cycler will be replaced.Tech support advised discontinuing use of the cycler.The has manual supplies and will confer with clinic regarding the next night's treatment.
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Manufacturer Narrative
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A visual inspection of the returned cycler exterior showed no sign of physical damage.There are visual indications of dried fluid within the cassette compartment.No burrs or sharps in cassette area that may have punctured a cassette membrane.A simulated treatment was performed and completed.No fluid leaks in the test cassette during the test treatment.An internal visual inspection of the cycler found evidence of dried fluid under pump ¿a¿ and ¿b¿ mushroom head and within the recess of the bottom cover adjacent to the pump.A device history record search found no related items.
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Event Description
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The patient contact reported that during the patient's previous night's treatment the cycler displayed m31 air detected in cassette.The patient was on a drain.The contact stated they ended the treatment.When the cycler door was opened to remove the cassette, it was noted that fluid was leaking.The cycler will be replaced.Tech support advised discontinuing use of the cycler.The has manual supplies and will confer with clinic regarding the next night's treatment.
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Search Alerts/Recalls
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