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On (b)(6) 2015, baxter product surveillance located in (b)(6), notified baxter (b)(4) technical services through email of a patient involved event; reporting multiple reports of 3 various devices.The mother of a patient, had contacted the baxter adverse event line because she was trying to find out what type of ingredients were used to manufacture the devices that was used in preparing her daughter's medication.The (b)(6) year old, patient a went through three anaphylactic reactions, all being severe and one being life threatening.Patient a was taking iv ceftriaxone and iv glutathione at the time.Patient a has a latex sensitivity.In (b)(6) of 2014, patient a began taking iv ceftriaxone at home as treatment for lyme disease.The patient took iv ceftriaxone for 7 weeks without incident.(b)(6) 2015, patient a had finished her ceftriaxone with no issues.The patient had flushed the line, waited a half hour and began to use the glutathione.Patient a began exhibiting a rash, her tongue became itchy, and she had problems breathing.Patient a's mother called 911.The ambulance came and administered an epi-pen, which stabilized patient a.Patient a, also received a benadryl drip at (b)(6).Patient a was observed for approximately 6 hours.Patient a was discharged and left with prescriptions for prednisone and instructions to take benadryl.(b)(6) 2015, patient a skipped her morning ceftriaxone.Since patient a's reaction occurred during the use of glutathione, patient (a) and her mother concluded that glutathione was the cause; as this was the new medication used.Patient (a) started her iv ceftriaxone and immediately noticed that her hands were itchy.Patient (a) and her mother immediately took out the iv and headed to the er at (b)(6).Patient a experienced the same reactions again, but her breathing was worse.Patient a's parents had a conversation with the er physician; it was assumed that patient a's reaction was delayed from the day before and that it was indeed the ceftriaxone that was causing the reaction.The use of ceftriaxone was discontinued.(b)(6) 2015, patient a was at her doctor's office getting blood work done.The mother of patient (a) had brought the glutathione and had it administered to patient (a).Patient (a) had the same rash from head to toe, eyes were dilated and glassy, and she couldn't breathe.She went unconscious and stopped breathing.Patient (a's) doctor started resuscitating her for approximately 20 seconds.An epi-pen was administered to patient (a.) patient (a) was taken to (b)(6), and the same protocol was followed as previously mentioned.Patient a has stopped all medication until the cause can be identified.This is 1 of 3 reports from the same event as it involved 3 different baxter healthcare devices.
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Additional investigations found that baxter healthcare devices did not contribute or caused the event reported.The devices that patient (a's) mother called to inquire about are latex free.(b)(6) 2015 - a scheduled phone call was made to patient (a's) mother.Patient (a's) mother did note that patient (a) was recovering and planning for college.When asked if the devices were available for return, the patient's mother replied that she was unsure if the devices were available or not.The patient's mother was going to start using a new pharmacy and allergist.(b)(6) 2015, as baxter global product surveillance attempted to and could not get in contact with the patient's mother for additional follow-up; baxter global product surveillance had contacted the 2 pharmacies that the patient's mother had previously mentioned.Drug: iv ceftriaxone.Instruction for use: 5 days on and 2 days off of the medication - once every 12 hours.Prime tubing first, infuse 2gm (100 ml or contents of this elastomeric pump) iv over one hour.The compliance officer at (b)(4) was contacted and additional information was provided.According to the compliance officer: the mother of the patient did contact the pharmacy to report anaphylactic reactions on (b)(6) 2015.(b)(4) conducted their own investigation and determined that (b)(4) did not provide baxter healthcare devices to the mother of patient (a,) or to patient (a).(b)(4) prepared and supplied this patient with pre-mixed medication in eclipse elastomeric pumps done by their trained technicians and pharmacist in their clean room.The drug: ceftriaxone is manufactured by hospira.The drug: ceftriaxone was prepared twice for the patient by (b)(4), on (b)(6) 2014.Each time that the medication was prepared was for a 14 day supply.(b)(4).Drug: iv glutathione.Instruction for use: take as a (b)(4) did provide baxter healthcare devices to the mother of patient a.The pharmacist at (b)(4) conducted their own investigation and found that patient (a) most likely, had an infused based reaction.The pharmacists does not believe that baxter healthcare devices contributed to this event.(b)(4).(b)(6) 2015, patient (a's) mother provided more information regarding this event.Patient a had not been regularly taking the glutathione.The manufacturer of the other devices used in patient a's treatment has been notified of this event.Method: design validation.Baxter healthcare's subject matter expert confirmed that this device is latex free and not made of natural rubber latex.Results: unk - unknown.The results are unknown as it cannot be determined who diagnosed patient a with latex allergy, where the latex contamination occurred or if the event even involved a latex reaction.Conclusion: device not returned.The patient's mother did not indicate that the devices were available for return.Device not available for return.
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