Catalog Number 5C4482 |
Device Problem
Failure to Disconnect (2541)
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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 there was a connection issue between a minicap transfer set and the patient line of the homechoice cassette.This occurred during use of the device for peritoneal dialysis therapy.The connection issue was further described as ¿uncapable to unscrew the patient line from the transfer set¿.As a result, the patient had to cut the patient line and the line was removed with pliers in the hospital¿.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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H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was discarded; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction made to a3: gender: female (previously submitted as male).Correction made to e1: initial reporter e-mail: (b)(6) (previously submitted as ni).Correction made to h6: type of investigation: replace b18 with b01.Correction made to h6: investigation findings: replace c20 with c1601 and c19.Correction made to h6: investigation conclusions: replace d15 with d0301 and d14.Correction made to h10: the device was received for evaluation with a mini cap attached to the female connector.A visual inspection with the naked eye noted a female connector separated from the main body and a twisted/blocked silicone tubing.The tubing was hand manipulated to completed a clear passage test with no issues.Clamp function testing was performed with no issues.Connection/disconnection testing was performed during leak testing with no issues or leaks observed, therefore the reported connection issue was not verified.The cause of the separation was due to an inadequate solvent application to the main body during manufacturing.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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