Events

Rappel de Covidien Kangaroo Connect Enteral Feeding Pump

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medtronic.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    73669
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1649-2016
  • Date de mise en oeuvre de l'événement
    2016-04-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144700
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Pump, infusion, enteral - Product Code LZH
  • Cause
    Kangaroo connect feeding pump occlusion alarms fail to alarm.
  • Action
    Medtronic(formerly) Covidien notified accounts via Urgent Medical Device Recall letter, dated 4/1/16, that specific serial numbers with software versions 1.12 and 1.13 have a software anomaly. The firm shipped replacement units with software V 1.14. Affected devices must be returned to the firm once the replacement units have been received. A Recalled Product Return Form required to be completed and returned. Questions or concerns, contact Medtronic representative or Customer Service at (800) 882-5878.

Device

Covidien Kangaroo Connect Enteral Feeding Pump
  • Modèle / numéro de série
    Serial Numbers: AS1400000006 AS1400000007 AS1400000008 AS1400000010 AS1400000011 AS1400000012 AS1400000013 AS1400000014 AS1400000015 AS1400000016 AS1400000017 AS1400000020 AS1400000022 AS1400000023 AS1400000024 AS1400000025 AS1400000026 AS1400000027 AS1400000028 AS1400000029 AS1400000031 AS1400000032 AS1400000033 AS1400000034 AS1400000035 AS1400000036 AS1400000037 AS1400000038 AS1400000039 AS1400000040 AS1400000041 AS1400000042 AS1400000043 AS1400000045 AS1400000046 AS1400000047 AS1400000049 AS1400000050 AS1400000051 AS1400000052 AS1400000054 AS1400000055 AS1400000057 AS1400000058 AS1400000059 AS1400000060 AS1400000061 AS1400000062 AS1400000063 AS1400000064 AS1400000065 AS1400000066 AS1400000067 AS1400000068 AS1400000069 AS1400000070 AS1400000072 AS1400000077 AS1400000078 AS1400000079 AS1400000080 AS1400000081 AS1400000082 AS1400000083 AS1400000089 AS1400000091 AS1400000092 AS1400000101 AS1400000103 AS1400000104 AS1400000105 AS1400000107 AS1400000108 AS1400000112 AS1400000113 AS1400000115 AS1400000116 AS1400000117 AS1400000118 AS1400000119 AS1400000120 AS1400000121 AS1400000122 AS1400000124 AS1400000126 AS1400000127 AS1400000128 AS1400000130 AS1400000131 AS1400000132 AS1400000133 AS1400000136 AS1400000139 AS1400000140 AS1400000141 AS1400000142 AS1400000143 AS1400000144 AS1400000145 AS1400000146 AS1400000148 AS1400000149 AS1400000150 AS1400000151 AS1400000152 AS1400000155 AS1400000157 AS1400000158 AS1400000160 AS1400000161 AS1400000163 AS1400000165 AS1400000166 AS1400000169 AS1400000170 AS1400000171 AS1400000173 AS1400000174 AS1400000178 AS1400000179 AS1400000180 AS1400000181 AS1400000184 AS1400000189 AS1400000190 AS1500000277 AS1500000376 AS1500000412 AS1500000416 AS1500000420 AS1500000444 AS1500000457 AS1500000479 AS1500000504 AS1500000515 AS1500000522 AS1500000526 AS1500000531 AS1500000555 AS1500000563 AS1500000711 AS1500000721 AS1500000728 AS1500000730 AS1500000739
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Australia, Canada, France, and Singapore.
  • Description du dispositif
    Covidien Kangaroo Connect Enteral Feeding Pump || Item Number: 584400 (OUS) || Intended to provide enteral nutrition to a patient for hospital and acute care settings.
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Adresse du fabricant
    Medtronic, 60 Middletown Ave, North Haven CT 06473-3908
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA