Model Number HS-001 |
Device Problems
Loss of or Failure to Bond (1068); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The affected device has not yet been returned to the distributor.
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Event Description
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On 06/10/2019, a distributor of infutronix reported a tubing detachment issue: "iv set tubing detached from distal end of cassette connector site".No information on the medication used at the time of the event was available.No patient information or injury was reported to infutronix.No information on the expiration date or manufacturing date of the affected device was available.The contract manufacturer of the affected device is podo xingda ((b)(4)) medical co.Ltd.
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Manufacturer Narrative
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The reported tubing detachment issue was confirmed.The administration set tubing was completely detached from the cassette on the distal end.No signs of physical damage were present.The administration set had a bonding issue at the cassette connector site (distal end).The affected administration set has been scrapped after testing.
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Event Description
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This is a follow-up for the initially filed mdr (3011581906-2019-00021).
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Search Alerts/Recalls
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