Catalog Number CON-HL-90 |
Device Problems
Overheating of Device (1437); Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A product sample was received and is awaiting evaluation and 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 reportable information becomes available.Udi is unknown, no product information has been provided to date.
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Event Description
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It was reported that the pump was bad/over heating.No patient injury was reported.Additional information was requested; however, no further information was received.
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Event Description
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Additional info received via email 6-sep-2022.The event occurred during preventive maintenance.No patient involvement.
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Manufacturer Narrative
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Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records the device was returned back with a cracked tank cover, and a wear and tear damaged front cover.The pump was noisy and running hot confirming, therefore the customer's complaint was confirmed.No action was taken, due to the age and condition of the device.It was deemed beyond economical repair and will be scrapped.A manufacturing device history record review was not performed because the results of the complaint d5 and e4 are unknown.Additional event information received indicating no patient involvement (updated b5).
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Search Alerts/Recalls
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