Model Number JK090 |
Device Problem
Crack (1135)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/15/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
|
|
Event Description
|
It was reported that there was an issue with jk090 - reusable filter for container.According to the complaint description, the filter were damaged/torn.Mainly, holes or cracks in the central circle are observed.It is difficult to say for sure how many passes these filters have undergone.The average estimate would be 190 passes with a minimum of 12 cycles and a maximum of 600.There was no described patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference#: (b)(4).Associated medwatch-reports: 9610612-2020-00892 - 400494548 - jk090; 9610612-2020-00893 - 400494549 - jk090; 9610612-2020-00894 - 400494550 - jk090; 9610612-2020-00895 - 400494551 - jk090; 9610612-2020-00896 - 400494552 - jk090; 9610612-2020-00897 - 400494553 - jk090; 9610612-2020-00898 - 400494554 - jk090; 9610612-2020-00899 - 400494555 - jk090; 9610612-2020-00900 - 400494556 - jk090; 9610612-2020-00901 - 400494557 - jk090; 9610612-2020-00902 - 400494558 - jk090; 9610612-2020-00903 - 400494559 - jk090; 9610612-2020-00904 - 400494560 - jk090.
|
|
Manufacturer Narrative
|
Investigation results: visual investigation: 10 filters have been received.9 filters are torn, 1 filter does not show any signs of tear.The torn areas are at 8 filters from the center hole out in direction of the outer edge of the filter.1 filter shows a rip slightly sideways above the center hole.The regular condition would be without any tears or damages.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that there are no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 2 (5) probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results there is capa is not necessary.Associated medwatches: 9610612-2020-00892 - 400494548 - jk090; 9610612-2020-00893 - 400494549 - jk090; 9610612-2020-00894 - 400494550 - jk090; 9610612-2020-00895 - 400494551 - jk090; 9610612-2020-00896 - 400494552 - jk090; 9610612-2020-00897 - 400494553 - jk090; 9610612-2020-00898 - 400494554 - jk090; 9610612-2020-00899 - 400494555 - jk090; 9610612-2020-00900 - 400494556 - jk090; 9610612-2020-00901 - 400494557 - jk090; 9610612-2020-00902 - 400494558 - jk090; 9610612-2020-00903 - 400494559 - jk090; 9610612-2020-00904 - 400494560 - jk090; 9610612-2020-00905 - 400494546 - jk090.
|
|
Search Alerts/Recalls
|