Model Number 8637-40 |
Device Problems
Occlusion Within Device (1423); Unstable (1667); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 05/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.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 via manufacturer representative regarding a patient who was receiving an unknown drug at an unknown concentration and dose via intrathecal drug delivery pump for non-malignant pain.It was reported that during a refill on (b)(6) 2018, the patient had a high residual volume of 37 ml aspirated from the pump.The patient had poor pain relief.There were no known environmental, external or patient factors that may have led or contributed to the issue.No diagnostics or troubleshooting were performed, and no interventions were taken to resolve the issue.Surgical intervention did not occur and it was unknown whether it was planned.The issue was not resolved and the patient status was "alive - no injury" at the time of this report.No further complications were reported.Additional information was received from the healthcare professional via manufacturer representative.It was reported that the expected residual volume at refill was 2 ml.Surgical intervention was not planned.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 the healthcare professional via manufacturer representative.It was reported that the old catheter was twisted and kinked at the spinal site.The distal end was left in-situ and tied off, and the remaining catheter was removed.The pump was flipped in the pocket and the sutures were broken.The old pump was removed.A new pump and catheter were implanted.No alarms were noted.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 the healthcare professional via manufacturer representative.It was reported that the product was not returned; the customer sent it to pathology per hospital protocol and did not request analysis.No further complications were reported.
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Search Alerts/Recalls
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