|
The device had failed and was found to have cracked posts on the bezel.Patient involvement was reported.The reported issues states: in the last two weeks, i have had two pumps from avante fail because of cracked posts on the bezels, one which is currently involved in a patient incident.Upon further investigation, it was reported that the patient expired.No additional patient event or details are available at this time.A follow up report will be submitted upon completion of device evaluation and additional information obtained.
|
|
Reportedly, the device had failed and found to have cracked posts on bezel.Patient involvement was reported.The reported issues states: in the last two weeks, i have had two pumps from avante fail because of cracked posts on the bezels, one which is currently involved in a patient incident.My concern is that these pumps had bezels with notches that look like valox bezels, but upon deeper investigation they are actually second-hand bezels made to look like valox from the outside.Report from (b)(6), director of biomedical engineering, dated (b)(6) 2021 the complaint device was not returned for evaluation.Ahs biomedical engineer traveled to henderson hospital, las vegas to provide an on-site device evaluation of the suspect device and additional suspected devices from this sales order: sa: 1110937 on (b)(6) 2021.The recent purchase of 100 alaris 8100 modules are suspected of containing up to 60 front bezels that could contain cracks in the mounting posts, in the threaded area inserts.A second pump module was suspected of over-infusing.This device was found in the shop, in line for remediation.The senior biomed technician (b)(6), opened the device while sequestered to inspect for points of failure.He then sent ahs pictures of the failed post mounts inside the device.The pictures showed breakage and separation of the post in the area of the threaded inserts, which could have caused the error reported.During containment, the initial 20 modules inspected contained 17 with bezel defects ranging from micro cracks to complete post breakage, and in some cases complete separation near the bottom of the threaded insert areas occurred.The bezel manufacturer was identified as tenacore.Immediate containment began with removing all suspected devices from service at the hospital.These devices were held in the hospitals biomed shop until the bezels could be replaced on each of the identified devices.The confirmed total number of modules potentially containing the suspect part is between 60 - 70 total.These were identified by serial numbers from a recent sales order of 100 devices.The bezels on all of the identified modules were replaced with the oem replacement bezel.These devices were tested, calibrated and preventative maintenance was performed as part of the manufacturer recommended quality assurance testing.The devices with the defective bezels did not fail while in use on a patient.As stated earlier, one other pump was suspected of an over infusion but could not be confirmed.It was determined that the pump in question, serial number (b)(6), did not contribute to the demise of the patient according to (b)(6) risk department.The patient was a terminally ill male in his 20's, not expected to make it through the night of his passing.The pump was believed to have given the error after the patient expired.Per brittany, the director of risk management and patient safety, due to hippa concerns, the patient log and other patient event details could not be disclosed.Additionally, the warranty sticker was tampered with, thus voiding the warranty on many modules including the sequestered device.No additional patient or event information is available.This type pf event will continue to be monitored.
|
