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Model Number 2110 |
Device Problems
Insufficient Flow or Under Infusion (2182); Communication or Transmission Problem (2896); Connection Problem (2900); Loss of Data (2903)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that the device did not recognize the cassette and data loss/the comm module was not communicating.It is unknown if there was patient involvement, no adverse patient effects were reported.
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Manufacturer Narrative
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B3: event date unknown.H3: 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 lot number was provided; therefore, a history record review could not be conducted.D4: udi and model number are unknown, d3, g1, and g2 email is: (b)(4).
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Manufacturer Narrative
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Corrected data: d4 ¿ udi.D9: date returned to mfg 12/5/2023.One device was returned for analysis.Visual inspection showed a worn downstream occlusion seal, scratched lcd lens, and a missing battery door.There was no evidence to review in the device's event history log.A functional test was performed and the reported issue was duplicated.The probable cause of the reported issue was due to the latch lock flex sensor and printed wiring assembly (pwa) board.A history review identified there was no indication that the complaint was related to the device within the review period.
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Search Alerts/Recalls
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