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Model Number 13827 |
Device Problem
Insufficient Flow or Under Infusion (2182)
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Patient Problems
Tachycardia (2095); Inadequate Pain Relief (2388); Cramp(s) /Muscle Spasm(s) (4521)
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Event Date 01/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A review of the device history record, which includes verification of all steps in the manufacturing of the pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging for subject pump was performed.The review did not identify any non-conformances, issues or capas associated with pump function.Device was not returned for additional evaluation and investigation.As additional physical investigation was not performed on the device, a definitive root cause could not be determined for the alleged issue.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).
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Event Description
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A physician working at a hospital initially contacted technical solutions to report that a patient had been hospitalized with tachycardia, increased pain, and cramping.Days later, a physician from a pain management office contacted technical solutions to report that a volume discrepancy was observed.Physician stated that 2.5ml were expected, and 25ml of clear fluid were pulled.Physician stated that they were certain that the needle was in the pump reservoir when aspirating.Physician also stated that when the tubing was disconnected from the needle, 3-4ml of additional fluid aspirated from the top of the needle.The physician reportedly refilled the pump with medication after the discrepancy was observed.It was reported that the patient did not have any recent mris.Technical solutions recommended to the physician that they remove the medication from the reservoir and refill with saline, but it cannot be confirmed if this was performed.Later communication between technical solutions and the physician from the pain management office confirmed that a dye study was performed.The dye study showed the catheter to be patent, but showed that the pump was still "not working".No further information was able to be obtained.The physician reported that the pump will be explanted and replaced, but the surgery has not been scheduled yet.
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Search Alerts/Recalls
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