Model Number 8637-40 |
Device Problems
Premature Elective Replacement Indicator (1483); Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Event Description
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Information was received from a healthcare provider (hcp) regarding a patient receiving dilaudid [16.5 mg/ml] at an unknown rate, clonidine [240 mcg/ml] at an unknown rate, and bupivacaine [240 mcg/ml] at an unknown rate via intrathecal drug delivery pump.It was reported that the pump alarmed and according to the logs it appeared to be a premature battery depletion issue.When the pump was interrogated the screen read: pump in safe state, reset occurred.The logs stated a low battery reset, although the elective replacement indicator (eri) for this particular pump was 13 months.The pump was replaced and the issue was resolved.There were no further complications reported/anticipated.
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Manufacturer Narrative
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Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a manufacturer's representative on (b)(6) 2017.The pump logs indicate that the pump at the minimum rate was infusing dilaudid [16.5 mg/ml] at an 0.100 mg/day, clonidine [240 mcg/ml] at 1.40 mcg/day, and bupivacaine [240 mcg/ml] at 0.102 mg/day.The logs show that on (b)(6) 2017, a reset occurred, reset occurred-low battery, and pump in safe state message.There were no further complications reported/anticipated.
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Manufacturer Narrative
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Analysis of the device found that there was high resistance in the pump battery.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was reported by the company representative on (b)(6) 2017.The rep reported that the pump had been programmed to minimum rate.It was also noted that the end result was that the pump was replaced and therapy was reinitiated without issue.The patient reported no adverse symptoms.
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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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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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