Device product
MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
Z-1571-2014
Product summary
- Event
- Event 67921
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90
- Official record key
device-enforcement:Z-1571-2014
Official wording
Reason: A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
Code information: Serial Numbers: NNBLTL, NNBLT5, NNBLR9, NNBLT2, NNBLJP, NNBLL2, NNBLJR, NNBLLH, NNBLLJ, NNBLLG, NNBLT0, NNBLT1, NNBLL7, NNBLTC, NNBLTN, NNBLTK, NPBLZ7, NPBLZH, NPBLZP, NPBLZN, NPBLZM, NPBLZK, NPBLZ4, NPBLZJ, NPBLY3, NPBLY5, NPBLY4, NPBLY7, NPBLZT, NPBLY9, NPBLZR, NPBL7M, NPBL74, NPBMFN, NPBMF0, NPBMHJ, NPBMHK, NPBL71 NPBL9H, NNBLLP, NNBLLN, NNBLLC, NNBLLD, NNBLL3, NPBL0F, NNBLTH, NPBL6N, NPBL6M, NPBL6L, NPBL1T, NPBL17, NPBL1Y, NPBL1W, NPBL75, NPBL70, NPBL76, NNBLG2, NPBMFG, NPBMF4, NPBMF2, NPBMF1, NPBMF5, NPBMH2, NPBMH0, NNBLJM, NNBLJK, NNBLJN, NNBLHZ, NNBLHW, NNBLH2, NNBLH1, NNBLH0, NNBLTB, NNBLL4, NPBL1R, NPBL1P, NPBL1N, NPBL1L, NPBL1J, NPBL9N, NPBL9K, NPBL9L, NNBLHN, NNBLGV, NNBLHT, NNBLHM, NNBLG0, NNBLLK, NMBKBW, NMBJ5G
Distribution pattern: Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.
Derived failure modes
-
Unknown
A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.