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Model Number 2110 |
Device Problems
Device Alarm System (1012); Pumping Stopped (1503); Key or Button Unresponsive/not Working (4063)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2023 |
Event Type
malfunction
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Event Description
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It was reported that during use, the device exhibited an occlusion alarm and resolution volume had not decreased since leaving the facility; however, it was believed that the pump was on and working while the patient was at the facility.Troubleshooting was attempted but the pump then showed ¿stopped¿ and the keypad appeared to not work; troubleshooting was unsuccessful, and the pump was powered off.Per the reporter, there were no adverse patient effects.
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Manufacturer Narrative
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Device not received by manufacturer.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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Manufacturer Narrative
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No product was returned.We are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.The most probable cause is the uso sensor and keypad; however, this cannot be confirmed as no product was returned for investigation.The service history review identified no indication that the complaint was related to a service of the device within the review period.
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Search Alerts/Recalls
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