|
Device Problem
Device Difficult to Setup or Prepare (1487)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/02/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that in a survey the following question was asked: "given the globally diverse range of iv bag sizes, the company pressure chambers have changed geometry by design.Do you have experience with iv bags not emptying in your pressure chambers?".Received response was: "couldn't close pressure chamber, took 1-2 minutes extra to fix as had out it together incorrectly".No further details were provided.No patient death or serious injury was reported.
|
|
Manufacturer Narrative
|
Event date is unknown.No catalog, model, lot or serial numbers were communicated; device expiration date and device manufacturing date not available.Device evaluation including root cause analysis is in progress.No product was returned for investigation.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.Additional information: the complaint information was provided from a 3rd party company who conducted a general post-market clinical follow-up (pmcf) activity on our company's behalf.Post-market clinical follow-up for this product family is required to comply with eu mdr requirements.This general pmcf activity consisted of interviewing clinicians anonymously about safety and performance of the level 1 hotline and fast flow temperature management systems at the asa (american society of anesthesiologists) anesthesiology conference from 21-october-2022 through 25-october-2022.Devices within the scope of this activity included intravascular devices only, not irrigation products.
|
|
Manufacturer Narrative
|
Other, other text: h6: health effect and evaluation codes: updated h10: no lot number was provided; therefore, device history record review could not be performed.No product sample nor photos were received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# 617147.
|
|
Search Alerts/Recalls
|
|
|