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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1682-2017

Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions

Publicado el 5 de abril de 2017 · Inicio del retiro: 30 de diciembre de 2016

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy can resume. AC power interruption of 3-7 seconds prompts an incorrect E323 alarm, ongoing therapy stop, and pump reboot. Longer power loss results in battery power operation.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Hospira Inc., A Pfizer Company
Distribuidor
Nationwide, Australia, New Zealand, Canada, Mexico, Chile, Philippines, Hong Kong, Greece, Ireland, Jordan, Kuwait, Oman, Poland, Saudi Arabia, Turkey, United Arab Emirates, Italy, France, United Kingdom, Spain
Lote
List number 30010; all products with software version 15.02 distributed prior to January 16, 2017. Serial numbers 19985403, 19985406, 19985408, 19985428, 19985439, 19985440, 19985450, 19985464, 19985878, 19985879, 19985880, 19985881, 19985882, 19985883, 19985884, 19985885, 19985886, 19985887, 19985889, 19985890, 19985891, 19985892, 19985893, 19985894, 19985895, 19985896, 19985897, 19985898, 19985899, 19985900, 19985901, 19985902, 19985903, 19985904, 19985905, 19985906, 19985907, 19985908, 19985909, 19985910, 19985911, 19985912, 19985913, 19985914, 19985915, 19985917, 19985918, 19985919, 19985920, 19985921, 19985922, 19985923, 19985924, 19985925, 19985926, 19985927, 19985928, 19985929, 19985930, 19985931, 19985933, 19985934, 19985935, 19985936, 19985937, 19985938, 19985939, 19985940, 19985942, 19985943, 19985944, 19985945, 19985946, 19985947, 19985948, 19985949, 19985950, 19985951, 19985952, 19985953, 19985954, 19985955, 19985956, 19985957, 19985958, 19985959, 19985960, 19985961, 19985962, 19985963, 19985964, 19985966, 19985967, 19985968, 19985969, 19985970, 19985971, 19985972, 19985974, 19985975, 19985976, 19985977, 19985978, 19985979, 19985980, 19985981, 19985982, 19985983, 19985984, 19985985, 19985986, 19985987, 19985988, 19985990, 19985991, 19985993, 19985994, 19985995, 19985996, 19985998, 19985999, 19986000, 19986001, 19986002, 19986003, 19986004, 19986005, 19986006, 19986007, 19986008, 19986009, 19986010, 19986011, 19986012, 19986013, 19986014, 19986015, 19986016, 19986017, 19986018, 19986019, 19986020, 19986021, 19986022, 19986023, 19986024, 19986025, 19986026, 19986027, 19986028, 19986029, 19986030, 19986031, 19986032, 19986033, 19986034, 19986035, 19986038, 19986039, 19986040, 19986041, 19986042, 19986044, 19986045, 19986046, 19986047, 19986048, 19986049, 19986050, 19986051, 19986052, 19986053, 19986054, 19986055, 19986056, 19986057, 19986059, 19986060, 19986061, 19986062, 19986063, 19986064, 19986066, 19986067, 19986068, 19986069, 19986070, 19986071, 19986072, 19986073, 19986074, 19986075, 19986076, 19986077, 19986078, 19986079, 19986080, 19986081, 19986082, 19986083, 19986084, 19986085, 19986086, 19986087, 19986088, 19986090, 19986091, 19986092, 19986093, 19986094, 19986095, 19986096, 19986097, 19986098, 19986099, 19986100, 19986101, 19986102, 19986103, 19986104, 19986106, 19986107, 19986108, 19986109, 19986110, 19986111, 19986112, 19986113, 19986114, 19986116, 19986118, 19986119, 19986120, 19986121, 19986122, 19986123, 19986124, 19986125, 19986126, 19986128, 19986131, 19986133, 19986135, 19986136, 19986137, 19986138, 19986139, 19986141, 19986142, 19986143, 19986145, 19986147, 19986151, 19986152, 19986153, 19986154, 19986155, 19986156, 19986157, 19986158, 19986159, 19986160, 19986161, 19986162, 19986164, 19986165, 19986167, 19986169, 19986171, 19986172, 19986175, 19986177, 19986178, 19986179, 19986180, 19986181, 19986182, 19986183, 19986185, 19986186, 19986187, 19986189, 19986190, 19986191, 19986192, 19986193, 19986194, 19986195, 19986196, 19986197, 19986198, 19986199, 19986202, 19986203, 19986204, 19986205, 19986206, 19986207, 19986208, 19986209, 19986210, 19986211, 19986212, 19986213, 19986214, 19986215, 19986216, 19986217, 19986218, 19986219, 19986220, 19986221, 19986222, 19986223, 19986224, 19986225, 19986226, 19986227, 19986228, 19986229, 19986230, 19986231, 19986232, 19986233, 19986234, 19986235, 19986236, 19986237, 19986239, 19986240, 19986242, 19986243, 19986244, 19986247, 19986249, 19986250, 19986251, 19986254, 19986255, 19986256, 19986257, 19986258, 19986259, 19986260, 19986261, 19986262, 19986263, 19986264, 19986265, 19986266, 19986267, 19986268, 19986269, 19986270, 19986271, 19986272, 19986273, 19986274, 19986276, 19986277, 19986278, 19986279, 19986280, 19986282, 19986283, 19986284, 19986285, 19986286, 19986287, 19986288, 19986289, 19986290, 19986291, 19986292, 19986293, 19986294, 19986295, 19986296, 19986297, 19986298, 19986300, 19986301, 19986302, 19986304, 19986305, 19986306, 19986309, 19986310, 199
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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