Model Number M443207E |
Device Problem
Defective Component (2292)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 11/01/2018 |
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, the customer noticed a leak coming from the parallel y-connector on the cardioplegia set.The product was replaced.There was no patient involved so no adverse effect occurred.Y-connector was part of the following custom pack: perfusion (b)(4) / lot number: 215621288.
|
|
Manufacturer Narrative
|
Visual analysis: visual inspection shows evidence of a crack/damage at the base of the "y" connector.Additional visual inspection shows the device is from mold cavity 1.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|