Model Number HSK-3043 |
Device Problem
Fitting Problem (2183)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/28/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Tw id#(b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
|
|
Event Description
|
Related to (b)(4).The hospital reported that during preparation for a coronary artery bypass procedure, hst iii system (4.3mm) when they pulled the delivery system out of the loading device, the seal had fallen off.The seal remains on the loading device.A new hs iii from a different lot was released, but the seal also fell off.The surgery was then completed using hsk-3038.There will be no delays in the process.The patient had no health problems.
|
|
Manufacturer Narrative
|
Trackwise #: (b)(4).The lot # 3000336049 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
|
|
Event Description
|
N/a.
|
|
Search Alerts/Recalls
|