Model Number M446913F |
Device Problem
Defective Component (2292)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 10/29/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received information that prior to use during priming of the custom tubing pack it was noted that there were holes in the parallel y connector.The pack was replaced.There was no adverse effect on the patient.
|
|
Manufacturer Narrative
|
The event date submitted in the original emdr is year valid only as 15 additional devices were found to have the same issue and the exact event dates are not available for the 15 additional occurrences.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Product analysis: visual inspection of the 16 returned connectors shows evidence of a crack/damage at the base of the "y" connector.Additional visual inspection shows all 16 are from mold cavity 1.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|