Model Number MPX5301-C |
Device Problems
Material Separation (1562); Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter: address unavailable.Bd (b)(6) address used.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that maxplus pressure rated extension set with needleless connector and y-site had the components separate.The following information was provided by the initial reporter: "we are having issues with this extension set pulling apart while connected to the iv pump line.".
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Event Description
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It was reported that maxplus pressure rated extension set with needleless connector and y-site had the components separate.The following information was provided by the initial reporter: "we are having issues with this extension set pulling apart while connected to the iv pump line".
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Manufacturer Narrative
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H6: investigation summary: no product or photo was returned by the customer.The customer complaint of extension sets pulling apart when connected to iv line could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model mpx5301 because a valid lot number was not provided by the customer.The root cause of this failure could not be identified without a failure investigation.H3 other text : see h10.
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Search Alerts/Recalls
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