Patient's bleeding was never controlled [device ineffective].Disseminated intravascular coagulation [disseminated intravascular coagulation].Patient's systolic blood pressure went down to 49 (unit not reported) [blood pressure systolic decreased].Jada system quality issue [product quality issue].Case narrative: this initial spontaneous report originating from the united states, was received from a clinical educator referring to a non-pregnant female patient.The patient's concurrent conditions included hypertension, multigravida (reported as g9) and multiparous (reported as 3 live births).The patient's medical history included abnormal postpartum uterine bleeding or hemorrhage, uterine dilation, and curettage (reported as 3 or 4 d and c's), abortion spontaneous and precipitous deliveries.Her concomitant medications were not reported.It was reported that on an unknown date in (b)(6) 2023, the patient had vaginal delivery at 38 weeks of gestation.The delivery was induced with high dose of oxytocin (pitocin) 42 (unit not reported).No epidural was given.Unspecified transfusions were given.The was no invasive placenta.The amount of blood loss prior to use of vacuum-induced hemorrhage control system (jada system) was 500 (unit not reported).This report concerned 1 patient and 1 device.On (b)(6) 2023, the patient underwent vacuum-induced hemorrhage control system (jada system) via intravaginal route (lot# and expiry date were not reported) placement, by midwife for postpartum hemorrhage.The device came with blue seal valve.The cause of the postpartum hemorrhage was suspected to be in disseminated intravascular coagulation (dic) (onset date captured as april 2023).The clinical educator reported that 120 cc was used for the seal per the nurses.But patient's bleeding was never controlled (device ineffective, onset date: (b)(6) 2023).They were unsure if it was a vacuum-induced hemorrhage control system (jada system) quality issue (product quality issue).As they were unsure if first device was functioning properly, so another vacuum-induced hemorrhage control system (jada system) (refer oars # (b)(4)) was used but bleeding continued.The patient's uterus was firm.The patient sought medical attention.The patient was in dic and was intubated taken to surgery and had hysterectomy.The patient was admitted into the intensive care unit (icu) (hospitalized) for treatment and was extubated the next day.The patient required blood transfusions due to 5-liter blood loss after use of the device (reported as collected in the vacuum-induced hemorrhage control system (jada system) canister).The patient's systolic blood pressure went down to 49 (unit not reported) (blood pressure systolic decreased, onset date captured as april 2023).It was also reported that the device was removed and then reinserted, and it wasn't operator's first time using the device.The vacuum-induced hemorrhage control system (jada system) was not available for evaluation as it was discarded.Causality of the events disseminated intravascular coagulation and blood pressure systolic decreased with the suspect therapy was unknown.Upon internal review, the event of device ineffective was determined to be serious as it required intervention.Upon internal review, the event disseminated intravascular coagulation was determined to be medically significant.The reporter considered the event blood pressure systolic decreased to be medically significant.This is one of the 2 reports received from the same source, referring to the same patient.When the lot number is unknown, a technical investigation of the specific manufacturing process which includes review of records associated with a known lot number cannot be performed.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).Fda code: (health effects - health impact per annex f): 4643 blood transfusion (patient required an infusion of whole blood or a blood component directly into the bloodstream.).
|