Catalog Number 82420 |
Device Problems
Misassembled (1398); Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/25/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation: photographs were submitted in lieu of the disposable set to aid in the investigation.Analysis of the images revealed a used trima loop assembly.The mini pinch clamp on the platelet line is not properly flossed on the tubing.The open end of the clamp is not assembled on the tubing.Because of this, the clamp cannot occlude the tubing.Based on the available evidence in the images provided, the root cause of the reported failure was a manufacturing mis-assembly.Correction: information regarding failures of this type is regularly shared with the relevant manufacturing teams.Investigation is in process.A follow-up report will be provided.
|
|
Event Description
|
The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product that occured during pas addition.Per the customer, the clamp was not correctly inserted in the set and could not be used as it was.An additional tubing clamp was used in order not to lose the product.Patient information and outcome are not available at this time.The platelet collection is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
|
|
Manufacturer Narrative
|
This report is being filed to provide additional information in b.5, h.6, h.10 and corrected information in a.1 and e.1.Investigation: the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Investigation is in process.A follow up report will be provided.
|
|
Event Description
|
There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.
|
|
Event Description
|
Updated information from the customer indicates the customer was able to use their own clamp to process the product without any problems, passing their internal qc (i.E.No elevated wbc count was alleged or confirmed by their testing).
|
|
Manufacturer Narrative
|
Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Per the customer, the "product could be processed and released normally.All subsequent examinations such as vitality or microbiology were inconspicuous." a disposable history search confirmed there were no occurrences of a similar issue reported on this lot worldwide.Root cause: the cause of the clamp failure was related to a misassembly, where the assembler neglected to follow the appropriate manufacturing operating procedure of the disposable set during manufacturing.More specifically, the mini pinch clamp was not adequately flossed onto the channel collect line tubing.
|
|
Search Alerts/Recalls
|