It was reported that a pump's settings were set as ordered by the provider.The patient called in stating that the pump was alarming and there were air bubbles in the tubing.The patient went in to the facility where nursing confirmed settings on the pump appeared correct.This was confirmed by three nurses.The pump indicated 62.45 ml given at continuous rate of 2.4 ml/hour and it stated reservoir volume was 47.3 ml.The bag in the cassette appeared empty and there was air in line.The pump was disconnected.The patient is experiencing adverse side effects, including diarrhea, abdominal cramping leading to hemorrhoid issues resulting in rectal pain/irritation for approximately 5 days.
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Other, other text: h6: event problem and evaluation codes: updates not required.H4: device manufacture date could not be completed due to lack of information regarding lot number.H10: device evaluation: the device was not returned for investigation, so no visual inspection and functional test were performed.Because no product was returned, the investigator was unable to confirm the reported complaint.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.No lot number was provided; therefore, device history record review could not be completed.
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