Catalog Number 21-7047-24 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
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Event Description
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It was reported that during use, the patient presented with device disconnected and began to leak around the screen of the pump.The device did not alarm or show any errors.The device was assessed by the nurse, and it was ¿just all white around pump and tubing of pump so not sure where the leak was¿.The nurse disconnected the pump.Per the reporter, there were no adverse patient effects.
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Manufacturer Narrative
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D9: date returned to mfg 2/27/2024.Device evaluation: one sample was returned for evaluation.Visual inspection revealed no damage or other defects.Functional testing revealed no anomalies; the device passed testing successfully.The failure mode was not confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
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Search Alerts/Recalls
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