Model Number 491346 |
Device Problem
Structural Problem (2506)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/27/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that bd totalys slideprep was not holding up.There were no injuries reported.The following information was provided by the initial reporter: replace black springs on centrifuge.There were no injuries reported.The site was not using the centrifuge due to springs not holding lid up.
|
|
Manufacturer Narrative
|
Device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
It was reported that bd totalys slideprep was not holding up.There were no injuries reported.The following information was provided by the initial reporter: replace black springs on centrifuge.There were no injuries reported.The site was not using the centrifuge due to springs not holding lid up.
|
|
Manufacturer Narrative
|
H.6 investigation summary complaint reports centrifuge lid issues associated with slideprep (catalog number 491346) serial number (b)(6).Complaint alleges centrifuge lid will not stay open, sometimes closing prematurely.Customer reported no injuries.Service replaced the lid springs and confirmed the centrifuge is operating normally.Root cause is attributed to faulty lid springs.This complaint is a confirmed failure of the centrifuge based on service investigation.Review of device history record for instrument serial number, (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.Device was installed on (b)(6) 2018.Service history review was performed for the instrument (b)(6), and no additional work orders were observed for the complaint failure mode reported.Review of risk management files confirms there are no new or modified risks associated with this failure mode.There are no corrective action plans or other corrections occurring.Bd quality will continue to monitor for trends associated with failure of "centrifuge." h3 other text : see h.10.
|
|
Search Alerts/Recalls
|