BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4482 |
Device Problems
Disconnection (1171); Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that three (3) minicap transfer sets "dislocated and was unable to match the titan key".This was discovered during use of the devices for peritoneal dialysis (pd) therapy.The transfer sets were replaced.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Additional information was added to h11: h11: the actual devices were not available; however, four (4) videos and four (4) photographs of the samples were provided for evaluation.The videos and photographs were reviewed and showed visual twisting rotation of the patient adapter and the patient adapter flushed to the titanium.However, without the actual samples, there is not enough information to duplicate the event or determine if the product failed or met specifications.The root cause of the event was undetermined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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