|
Device Problem
Device Difficult to Setup or Prepare (1487)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
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.
|
|
Event Description
|
It was reported that in a survey the following question was asked: "does the level 1 fluid warming device set up allow for rapid deployment and ease of use in an emergency situation?" response was: " especially with air detection if aril lock goes whole system glitches and have to revert to another device.Too general an issue, others set up the device so aware of issue but no specifics for a complaint form".No further details were provided.No patient death or serious injury was reported.
|
|
Manufacturer Narrative
|
No product or photographic evidence were provided to aid in this investigation.As a result, a complaint investigation / product evaluation and problem confirmation cannot be performed.Lacking any additional evidence in the complaint file attachment, and details in the complaint description, a probable cause could not be determined.Therefore, this complaint has been closed as unconfirmed.If the product is returned, this complaint will be reopened for further investigation.Cannot perform a device history record (dhr) review because there is no part number or serial number provided by the customer.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
|
|
Search Alerts/Recalls
|
|
|