CODMAN & SHURTLEFF, INC. A JOHNSON & JOHNSON COMPANY CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Device Problems
Excess Flow or Over-Infusion (1311); Nonstandard Device (1420)
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Patient Problems
Pain (1994); Paresis (1998); Impaired Healing (2378); Confusion/ Disorientation (2553)
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Event Date 11/01/2017 |
Event Type
Injury
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Event Description
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On (b)(6) 2017: patient started having issues with the infusion pump and catheter.Pt felt a large amount of medication been delivered by the infusion pump.A week later, pt started having delusional thought.Pt was having severe back pain and he went to his doctor and he was told the pump needed to be taken out due to pump failure.The pump caused swelling to his leg and pt lost sensation to his feet.Pt stated he was some how retaining medication.The pump was taken out on (b)(6) 2018 and pt is feeling better.The swelling in his leg is gone but there is a possibility that he might lose his big toe due to non-healing wound.Pt is still suffering from ed, low testosterone and he has lost 108 lbs.The pump has been recalled.
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