Catalog Number 89-8510-440-10 |
Device Problems
Break (1069); Mechanical Problem (1384); Separation Failure (2547)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 11/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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The device was not returned to the manufacturer at the date of this report.A follow-up medwatch will be submitted once the investigation is completed or if any additional information is received.
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Event Description
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It was reported that the aseptic transfer kit housing part number 89-8510-440-10, lot number 5009013 was broken.During the event, another device, aseptic transfer kit housing part number 89-8510-440-10, lot number 5010442 was also detected as broken.The surgery was delayed between 30 to 45 minutes due to the time needed to change the products.There was no additional harm or injury to the patient or operator reported.
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Event Description
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It was reported that the aseptic transfer kit housing part number 89-8510-440-10, lot number 5009013 was broken.During the event, another device, aseptic transfer kit housing part number 89-8510-440-10, lot number 5010442 was also detected as broken.The surgery was delayed between 30 to 45 minutes due to the time needed to change the products.There was no addtional harm or injury to the patient or operator reported.
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Manufacturer Narrative
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Aseptic transfer kit housing, lot number 5009013 was returned for complaint investigation.Visual and functional test ere performed.Upon receipt, it was confirmed that the lid was not closing properly and the locking system was disassembled.Device was not repairable, it was recycled in zimmer geneva premises according to customer instructions.The event date was reported as unknown.
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Search Alerts/Recalls
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