Model Number 8637-40 |
Device Problems
Device Alarm System (1012); Premature Elective Replacement Indicator (1483)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/29/2019 |
Event Type
Injury
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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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Event Description
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Information was received from a healthcare professional (hcp) regarding a patient who was receiving clonidine 120 mcg/ml; 87.02 mcg/day and dilaudid (hydromorphone) 20 mg/ml; 14.504 (primary) mg/day via an implantable pump.Indication for use was non-malignant pain and failed back syndrome.The date of the event was (b)(6) 2019.It was reported the patient was in for a refill on (b)(6) 2019 and upon interrogating the logs, it stated that elective replacement indicator (eri) occurred on (b)(6) 2019.The eri was not expected.An alarm was not heard but was confirmed by telemetry.At the previous refill, eri was not to occur till (b)(6).No symptoms were reported.No further complications were reported.
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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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Event Description
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Additional information was received from a healthcare professional (hcp).The cause of the premature elective replacement indicator was not determined.The pump was replaced on (b)(6) 2019.
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Search Alerts/Recalls
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