Model Number 8637-20 |
Device Problems
Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dyspnea (1816); Overdose (1988); Tachycardia (2095); Reaction (2414); No Known Impact Or Consequence To Patient (2692)
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Event Date 02/21/2017 |
Event Type
Injury
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Manufacturer Narrative
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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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Information was received from a healthcare professional (hcp) and a manufacturer's representative (rep) regarding a patient receiving 1 mg/ml dilaudid at a dose of 0.2498 mg/day via an implantable infusion pump for non-malignant pain.It was reported that at initial pump implant 1-2 weeks ago the patient had saline put in the reservoir of their pump.On (b)(6) 2017 dilaudid was placed in the pump reservoir and instead of doing a 0.391 ml priming bolus, a 0.540 ml bridge bolus over the duration of 51 hrs and 53 min was programmed.The patient was in the emergency department (ed) and had overdosed and was receiving narcan.The symptoms resembled more of an allergic reaction to the intrathecal medicine but the hcp did not know for sure what the issue was.The patient had a fast heart rate, heavy breathing, and was responsive to the narcan.The narcan cleared up some of it but the hcp was still testing for other possible medical issues.The rep reported that the bridge bolus was not going to end until later in the afternoon of (b)(6) 2017.The pump was programmed to minimum rate and the bridge bolus was cancelled.The hcp reported that the patient did have a urinary tract infection (uti) that was diagnosed on (b)(6) 2017.Additional information was received on (b)(6) 2017 from a healthcare professional (hcp).It was reported that during a removing system contents procedure the hcp had already done 2 primes and aspirations of 0.15 mls and wanted to confirm the final prime.It was confirmed that the final prime would be the catheter volume only- pump tubing not included.
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Manufacturer Narrative
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The main component of the device system; the other relevant components include: product id: 8840, product type: programmer, physician.(b)(4).
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Event Description
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Additional information received on 2017-apr-10 from a healthcare professional reported a pain pump error.Previous information was reported that was previously mentioned.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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