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On (b)(6) 2022,(b)(6), a biomedical engineer with (b)(6) hospital, (b)(6), reported a device malfunction pertaining to the accuvein av500.The malfunction occurred as the av500 was being used to support placement of a peripheral intravenous catheter (pivc).In this specific case, the clinical user was a bedside nurse who works the midnight shift.The nurse noticed that the avs00 laser projection was inaccurate while attempting to start an iv but didn't report it and people continued to use it until a second user reported the same inaccuracy of the location of veins.The nurse did not know any patient information.It was in general that she noticed the device did not work.The nurse stated that she stopped using the accuvein and was more successful, the nurse started talking to another nurse who also stated they are unable to insert ivs without missing the vein.No injuries were reported.There is no description of any of the patients, the nurse inserted peripheral iv lines; only on this unit.The actual date of the malfunction is unknown.The date of (b)(6) 2022 is the date that bio med contacted accuvein.The nature of the complaint is that when the device was being used to start an iv on a patient, the image of the vein was not centered and either was to the right of the view glass or left.This malfunction caused multiple nurses to question the device and reported it to the biomed and at that point it was removed from use for repair.The device was reported to accuvein as there was a presumption it wasn't working properly after a pattern of missed iv insertions.There was no injury to any patients.The inconvenience of being stuck again was the only issue.A corrective action, preventive action (capa) was opened; capa (b)(4).Upon further investigation in our facility, accuvein's chief scientist, dr.(b)(6), was able to reproduce the malfunction on the device in question.The probable cause relates to a previously opened capa (b)(4), which applies to defective screws used by benchmark electronics, inc.(bei) (accuvein's contract manufacturer) in the manufacturing process for av500s.The review is presented below: this unit contained screws from a manufacturing lot of screws that were determined by benchmark electronics to contain screws that were out of specification.Screws are used to align the lasers in the scan engine.The scan engine using these screws was built in april 2022.Two (2) broken screws were identified in the unit.The unit functioned without any fault codes being presented on the display screen.The vein offset still existed in the projection.The reason why this unit does not display a fault code and become inoperable, is because the laser offset is almost exactly sideways and the lpm sensor does not notice the sideways offset in the laser beams that are very wide where they hit the lpm sensor.When the screws used for aiming and retaining a laser in its calibrated position are broken, the laser can move, and then can be expected to display, as designed, a fault code dependent upon which laser screws were broken.The laser beam has an elliptical shape within the engine until it hits the fast mirror (which is circular).The elliptical shape of the laser beam means that the beam can move much further in the sideways direction (x-axis) than the vertical direction (y-axis) before the unit shows a fault code due to its inability to read laser feedback.If the screws are missing in such a pattern that they allow the laser to move in the sideways directions, then this should be more likely.This means the device will continue to appear to operate normally until the beam stops hitting the feedback sensor, but have an operational inaccuracy between the projected location of veins and the actual location of veins caused by the difference in ir and green laser positions.After review by accuvein, the device was returned to benchmark electronics (bei), accuvein's contract manufacturer, for repair.A synopsis of benchmark electronics repair report is presented below: per benchmark investigation repair report the device displayed fault codes: 10 and 22 on the display; a damaged heatsink and engine was found.Confirmed reason for return.Replaced heatsink; replaced engine; replaced battery on (b)(6) 2022.Complainant contact history: the accuvein complaint handling unit (chu) tier 2 engineer, (b)(6), opened case: (b)(4) on (b)(6) 2022.The engineer made numerous attempts to contact the complainant in order to collect the information required by 21 cfr 803.52 (subpart e).The following is a detailed contact log between the accuvein complaint handling unit (chu) and the complainant.Case (b)(4) logged by (b)(6) 2022 (10:25 am): case (b)(4) was opened.Biomed (b)(6) called accuvein customer support and reported to me that their avs00 laser projection is slightly off.All the relevant details were recorded in the salesforce.Com case.(b)(6) 2022 (logged 4:19 pm): i made multiple phone calls to the reporter, biomed (b)(6).(b)(6) did not answer these phone calls and had a full voicemail inbox.I asked (b)(6) (accuvein's customer service director at the time) if i would be able to ask (b)(6) for the required information "patient name or other identifier; patient age at the time of event, or date of birth; patient gender; and patient weight.In an email.(b)(6)2022 (11:41 am): per (b)(6) recommendation that i first try to reach the actual clinical users that first experienced the issue, i requested the clinical user's name, phone number, and email address in an email to (b)(6).On (b)(6) 2022 (logged 10:25 am): another phone call was made to (b)(6) after there was no reply to the email sent on (b)(6) 2022.(b)(6) picked up this time and said that the clinical user who first noticed the veins being misaligned was (b)(6), and her email address was provided.On (b)(6) 2022 (logged 5:30 pm): i called the hospital and asked the operator if i could speak with (b)(6); 11.E operator informed me that there is no record of a (b)(6) working at the hospital.(3:14 pm) i sent an email to (b)(6) and (b)(6) asking for the best phone number to reach (b)(6) at and for the best time to call.On (b)(6) 2022 (3:15 pm): an automated email response from the mail delivery system said the email sent on (b)(6) 2022 was not able to be delivered to (b)(6) email.On (b)(6) 2022 (logged 11:41 am): i tried calling the hospital operator again and instead asked to be transferred into 6 west, the department that the av500 had been used in.Once i was directed into 6 west, i spoke with a nurse who said that (b)(6) was there but had a ton of conference calls that day and likely would not be able to speak.I left a message with the nurse and provided her with a callback number.(11:11 am) i sent another email to (b)(6) requesting that he email me (b)(6) exact email address so that i could copy and paste it.I received a reply to the email sent on (b)(6) from (b)(6), who restated (b)(6) email address and the department the device complaint originated from.(12:55 pm) i sent another email requesting the name and phone number of the clinical user who first discovered the complaint to (b)(6) confirmed email address and cc'd (b)(6).This time i sent the email from my employee email through outlook instead of salesforce.Com in attempt to bypass any filters that may bounce the email.(b)(6) 2022 (logged 11:09 am): i called the hospital operator again and was transferred into 6 west where i spoke with a nurse who transferred me to (b)(6) direct line where i left a voicemail.I then called the hospital again and was transferred into 6 west where i spoke with a nurse who did not know of the complaint but said she would let the charge nurse; (b)(6) know that i called.(11:09 am) i sent another email from my employee email through outlook requesting the name and phone number of the clinical user who first discovered the complaint to (b)(6) and cc'd (b)(6).On (b)(6) 2022 (logged 10:58 am): i called the hospital again and was transferred into 6 west, where i was able to speak with the charge nurse, (b)(6).(b)(6) said that she was not there on the day the complaint was discovered, and that (b)(6) was the person to speak to.(b)(6) said that (b)(6) was probably in a meeting and transferred me over to her line where i left another voicemail.(logged 4:47 pm) later that day i called the hospital again and was transferred into 6 west where a nurse told me that (b)(6) leaves at 4:00 pm and that i should call at 9:00 am tomorrow.She then transferred me to (b)(6) line where i left another voicemail.On (b)(6) 2022 (logged 10:22 am): i called the hospital and was transferred into 6 west where i was then able to be transferred to (b)(6) line.(b)(6) picked up this time and explained that the clinical user was a nurse who works the midnight shift.The nurse noticed it while attempting to start an iv but didn't report it and people continued to use it until a second user reported it.(b)(6) was then called into confirm, and she reported the malfunction to biomed (b)(6).I alerted (b)(6) that i had successfully contacted (b)(6) and am waiting for the next steps.On (b)(6) 2022 (12:10 pm): the hipaa training modules are uploaded into arena.On (b)(6) 2022 (logged at 9:52 am): (b)(6)provided the relevant literature and forms to collect all the required information.I called the hospital and was transferred into 6 west where a nurse transferred me to (b)(6) line where i left her a voicemail.I called again shortly after my first call of the day and this time i was transferred into 6 west, and i left a message and my number with a nurse asking her to have (b)(6) call me back when she is available today.(b)(6) 2022 (9:05 am): i called the hospital and was transferred into 6 west where the line rang a couple times and then the call was ended.(9:30 am) i called the hospital again and was transferred into 6 west where a nurse informed me that (b)(6) does not work today.(1:49 pm) after receiving approval to do so, i sent (b)(6) an email via outlook.In this email i requested her direct phone number, her availability for a phone call (b)(6) 2022, and all the following information that she is required to provide us with regarding the complaint: name or other identifier of each patient treated while the device was malfunctioning (after the first notice until it was removed from use).Age at treatment or date of birth of each patient treated while the device was malfunctioning (after the first notice until it was removed from use).Race/ethnicity of each patient treated while the device was malfunctioning (after the first notice until it was removed from use).Gender of each patient treated while the device was malfunctioning (after the first notice until it was removed from use).Weight of each patient treated while the device was malfunctioning (after the first notice until it was removed from use).How was this problem identified: injection of vaccine, pharmaceutical, blood draw, or a pivc or picc? what were the outcomes during each treatment preformed (life threatening injury or illness, disability resulting in permanent impairment of a body function or permanent damage to a body structure, injury or illness that requires intervention to prevent permanent impairment of a body structure or function)? date that each patient was treated while the device was malfunctioning (after the first notice until it was removed from use); description of each treatment using the faulty device, including a discussion of how the device was involved, nature of the problem, patient follow-up or required treatment, and any environmental conditions that may have influenced the event; other relevant patient history including preexisting medical conditions of each patient treated; (2:03 pm) (b)(6) replied to my email explaining that she already spoke to someone about the situation last week and asked if there would be a weekly continuation of calls.(b)(6) also asked what information is needed outside of what she already has stated.(2:31 pm) i replied to (b)(6) email explaining that i have highlighted all the additional required information from my previous email in bright green.I also explained that there will not be a weekly continuation of calls, but that we need to collect all the requested information that they have regarding this complaint.On (b)(6) 2022 (9:07 am): (b)(6) replied to my email saying that she only saw the fields highlighted in yellow and didn't see any green areas.She also said she doesn't see an attachment.She requested that i resend the information needed over email.On (b)(6) 2022: (b)(6) is on pto.On (b)(6) 2022 (9:14 am): i replied to her email saying that i was attaching all the previous emails as they appear on my end, and that i would also re-send the information needed in this email as well.I stated that the following information still needs to be collected as required by the fda: name or other identifier of each patient treated while the device was malfunctioning (after the first notice until it was removed from use); age at treatment or date of birth of each patient treated while the device was malfunctioning (after the first notice until it was removed from use) race/ethnicity of each patient treated while the device was malfunctioning (after the first notice until it was removed from use).Gender of each patient treated while the device was malfunctioning (after the first notice until it was removed from use).Weight of each patient treated while the device was malfunctioning (after the first notice until it was removed from use) how was this problem identified: injection of vaccine, pharmaceutical, blood draw, or a pivc or picc? what were the outcomes during each treatment preformed (life threatening injury or illness, disability resulting in permanent impairment of a body function or permanent damage to a body structure, injury or illness that requires intervention to prevent permanent impairment of a body structure or function)? date that each patient was treated while the device was malfunctioning (after the first notice until it was removed from use).Description of each treatment using the faulty device, including a discussion of how the device was involved, nature of the problem, patient follow-up or required treatment, and any environmental conditions that may have influenced the event.Other relevant patient history including preexisting medical conditions of each patient treated i also requested a phone number and availability to collect as much of this information as possible over the phone (b)(6) 2022.I downloaded a pdf of all the previous emails and attached it to this email.On (b)(6) 2022 (2:50 pm): (b)(6) replied to my email stating "unfortunately, i spoke with one nurse who told me about the device, and i then reported it.She doesn't know any patient information.It was in general that she noticed the device didn't work.The nurse stated that she stopped using the accuvein and was more successful locating veins.The nurse started talking to another nurse who also stated they are unable to insert ivs without missing the vein.I simply reported the device to be checked by biomed." there is no description of any of the pts.The nurse inserted peripheral iv lines; only on this unit.The actual date is unknown.I would use the date that biomed contacted the company.The nature of the complaint is that when the device was being used to start an iv on a patient, the vein was not centered, and either was to the right of the view glass or left.This malfunction caused multiple nurses to question the device and report it to the writer and at that point it was removed from the clinical unit for repair.You may use my name in the report as well as the information listed below.(b)(6) may have the history of the actual report in (b)(6).I specifically told the tech what was wrong at that time.The tech brought accuvein from another unit to compare.Together the tech and i could see on our arms, the view was slightly off, and the device was turned in.We don't have any patient information.The device was reported because there was a presumption it wasn't working properly after a pattern of missed iv insertions.There was no injury to any patients.The inconvenience of being stuck again was the only issue.
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