Model Number 8637-40 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591); Application Program Problem (2880)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/22/2012 |
Event Type
malfunction
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Manufacturer Narrative
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The other relevant components include: product id: 8840, serial# unknown, product type: programmer, physician (b)(4).
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Event Description
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Information was received from a healthcare professional via a manufacturer representative regarding a patient receiving dilaudid (hydromorphone) 10mg/ml for an unknown total dose via an implantable pump for non-malignant pain and failed back surgery syndrome.It was reported patient got a new follow up healthcare professional (hcp) and was confirming in the first set of logs that the end of service occurred on (b)(6) 2012.The second set of logs was all question marks for the dates and the third set of logs showed (b)(6) 2020.Manufacturer representative (rep) was inquiring what this issue was.It was troubleshooted with rep confirming relevant information per rep's inquiries.Rep will confer with the hcp.No medical symptoms were reported and the location of symptoms was other.Event date was noted to be (b)(6) 2012.No further complications were reported/anticipated.
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Event Description
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Additional information received from manufacturer representative (rep) non (b)(6) 2017 reported this was a new patient the healthcare professional (hcp) was seeing.It was determined by us and tech services that the pump had been dead as of (b)(6) 2016.It was noted that was why the dates were different every time the logs were read.The patient is fine and the pump is going to be replaced the pump in (b)(6).No further complications were reported/anticipated.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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