| Model Number N/A |
| Device Problems
Partial Blockage (1065); Fluid/Blood Leak (1250)
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| Patient Problems
Hemorrhage/Bleeding (1888); Sepsis (2067); No Code Available (3191)
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Event Type
Death
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Manufacturer Narrative
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Date of event: (b)(6) 2008 -(b)(6) 2018.Product code: gbw.Pma/510(k) #: exempt.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
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Event Description
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It was reported to cook in a literature article titled "challenges of acute peritoneal dialysis in extremely-low-birth-weight infants: a retrospective cohort study" that peritoneal dialysis (pd) was performed on 12 extremely-low-birth-weight (elbw) infants with acute kidney injury (aki).Cook devices are believed to have been used on six of these patients.This report focuses on patient 1.Of the 12 selected patients, seven were male and five were female.The mean gestational ages and birth weights among the selected patients were reported to be 27.2 (± 3.3) weeks and 706.5 (± 220.5) grams.None of the infants had congenital defects of the genitourinary system.Using the neonatal kdigo aki classification, nine of the patients were classified as stage 3 while the remaining three were classified as stage 2.Two of the patients had aki due to multiple organ dysfunction syndrome (mods) after asphyxia in the delivery room.Two patients started treatment due to bilateral renal vein thrombosis.Ten of the patients were administered inotropes prior to their aki diagnosis.All patients were admitted to the user facility's nicu.Five had accompanying congenital heart disease and twin-to-twin transfusion.Specific patient details for these are unknown.The dialysis technique used was described to be the same for all patients.The catheters were inserted bedside as the patients did not have favorable conditions for transportation to the operating room.Under sterile conditions and using local anesthesia, 20-gauge guide needles were inserted at the counter-mcburney point ("the point over the left side of the abdomen that is one-third of the distance from the anterior superior iliac spine to the umbilicus") and were used to administer 3-5 ml of sterile saline.The insertion site of the catheter was checked via abdominal sonography prior to puncture.After the guide needle was inserted, contents of the syringe were assessed to "check for the presence of bowel injury".Following, an iv canula/pd catheter was inserted using a guide wire for peritoneal access.Four brands of catheters were used in this study, one being cook, prompting this report and the associated reports.Using simple x-ray, the location of the catheter tip was evaluated.The pf catheter tip "was placed in the lower portion of the pelvis".Pd was started immediately following catheter insertion.It was written that "dialysis solutions (hemosol or physioneal) were used at standard hydrous dextrose concentrations of 2.5 and 4.25% with osmolalities of 396 and 485mosm/l.To optimize ultrafiltration, the concentration of the dextrose in the dialysate was increased sequentially from 2.5 to 4.25% while monitoring the blood sugar level.Pd was started at a rate of 10 ml/kg, which was increased to 20¿ 30 ml/kg at 60¿120min/cycle continuing for 24 h; e.G.Starting with input time, 20-min dwell time, 10-min outflow, 30min in case of 60min)".The concentration of pd fluid was increased in four patients from 2.5% to 4.25% due to insufficient drainage, but was decreased in one patient from 4.25% to 2.5% due to hyperglycemia.The dwell time was set at a drainage period of 10min at this stage.Regarding changes in dwell time, it was written that "the initial pd cycle yielded an exchange inflow of 10 ml/kg for 10 min, a dwell time of 30 min, and a drain time of 20min.We adjusted the dwell time and dextrose concentration of the dialysis fluids according to ultrafiltration (uf)".All complications and patient outcomes were evaluated based on clinical manifestations as well as results of biochemistry/serology studies, simple x-rays, and echocardiography.Regarding overall results, it was written that "the average rate of reduction in the serum bun and cr levels during dialysis was 42.5% (range, 12¿64%) and 20.1% (range, 0¿70%), respectively.The sodium levels increased from 135.8 to 144.7mg/ml, and the potassium levels decreased from 6.8 to 5.0 mg/ml after 9.3 (±4.4) days".Patient 1 is the subject of this report.Their gestational age (weeks) was reported to be 25 + 1.Their birth weight was 960 grams.Their cause of aki was reported to be sepsis with an 8-day onset.A 9 fr pd catheter was used on this patient with a dwell time of 80 minutes reduced to 30 minutes.The uf rate (ml/kg/h) was 0.72.Bun pre-/post-pd (mg/dl), cr pre-/post-pd (mg/dl), sodium pre-/post-pd (mg/dl), and potassium pre-/post-pd (mg/dl) values were reported to be 74/65, 4.73/3.15, 147/140, and 5.7/3.Urine output pre-/post- pd (ml/kg/h) was.1/0.Complications included dialysate leakage ("resolved after adjustment of the dwell volume or reinsertion of the catheter on the other side"), intraperitoneal hemorrhage, and catheter obstruction.This patient had a ttts recipient comorbidity.Their death was attributed to both sepsis and mods.Additional information regarding the patients, devices, and events, as well as clarification, was requested but is not available.All events associated with this literature are reported under patient identifiers: (b)(6).Noh, j., kim, c.Y., jung, e.Et al.Challenges of acute peritoneal dialysis in extremely-low-birth-weight infants: a retrospective cohort study.Bmc nephrol 21, 437 (2020).Https://doi.Org/10.1186/s12882-020-02092-1.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Investigation evaluation: dialysate leakage, intraperitoneal hemorrhage, and catheter obstruction was reported in the literature article ¿challenges of acute peritoneal dialysis in extremely-low-birth-weight infants: a retrospective cohort study¿ bmc nephrology journal.¿ the complaint device was reported to be a cook acute peritoneal dialysis set (rpn: c-pds-901t-15, lot number unknown).The patient¿s gestational age was 25 + 1 days and they weighed 960 grams.The cause of their acute kidney injury (aki) was sepsis and the onset was 8 days.The patient had twin to twin infusion syndrome and was the recipient.It was reported in the literature that the dialysate leakage was resolved after adjustment of the dwell volume or reinsertion of the catheter on the other side.The intraperitoneal hemorrhage occurred at either insertion or removal of the catheter.For this patient, the dwell time was reduced from 80 to 30 minutes.The uf rate was 0.72 ml/kg/h.The bun pre pd was 74 mg/dl after pd it was 65 mg/dl.Creatinine per pd was 4.73 mg/dl and post pd it was 3.15 mg/dl.Sodium pre pd was 147 mg/dl and post pd 140 mg/dl.Potassium pre pd was 5.7 mg/dl and post pd 3 mg/dl.Urine output pre pd was 0.1 ml/kg/h and post pd 0 ml/kg/h.As soon as dialysis was performed, the neonate died from multiple organ dysfunction syndrome (mods) caused by sepsis, respiratory failure, and congestive heart failure.A review of the complaint history, instructions for use (ifu), and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.Given the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The cook acute peritoneal dialysis set is supplied with ifu c_t_pds_rev7 which includes the following: ¿precautions for catheters with a cuff, in order to obtain the tightest possible seal of the tissues are the catheter and minimize the risk of dialysate leakage to the outside during the early phase of catheter use before tissue ingrowth in the cuff is complete, advance the assembly into the peritoneal cavity without cutting a larger hole for the wire guide.Instructions for use 1.The usual puncture site is below the umbilicus, one-third of the distance from the umbilicus to the symphysis pubis.¿ based on the information provided, no product returned, and the results of the investigation, a definitive root cause for this event was unable to be established.It is possible that a selection of the left side as opposed to the midline contributed to dialysate leakage, intraperitoneal hemorrhage, and catheter obstruction.Additionally, no information was provided regarding the specific catheter insertion procedure.Manipulation of the device as well as routine care may have contributed to the event; adjustment of dwell time by manipulating/accessing the catheter/three-way tap increases the risk of insertion site leakage.It is also assumed that an infant of this age and weight was likely mechanically ventilated, potentially with high-frequency ventilation.If so, ventilation vibrations may lead to movement of the device, resulting in leakage around the insertion site.A 9 french pd catheter was used in this patient, which is a large size in relation to the size of the baby as well as the lack of subcutaneous tissue and the neonate's thin skin, which likely contributed to the leaking and may have contributed to the intraperitoneal hemorrhage as it was stated that it occurred during insertion or withdrawal.Hemorrhage is a known procedural risk of using this device with a wire guide in a premature infant.It should also be noted that premature neonates with sepsis can be very difficult to treat, and sepsis may lead to conditions such as dic, which may have exacerbated the hemorrhage.Therefore, the cause of both the leakage and hemorrhage can likely be traced to the patient's size/condition and user/procedural issues, including catheter size selection and insertion/withdrawal technique.Blockage can occur when the catheter tip or side ports are positioned against a structure (i.E.Stomach, spleen, liver, duodenum, jejunum, peritoneum).Catheter manipulation or movement may also have caused the device to misplace from the intended location, or kink the lumen resulting in blockage.Details of the catheter obstruction were not provided.Biomatter may have caused the obstruction, especially considering that an intraperitoneal hemorrhage was also reported.Fibrin can be present in the peritoneal cavity due to infection, inflammation, and reaction to the peritoneal dialysate solution.Fibrin can accumulate within the catheter and cause blockage.At this time, the results of the investigation indicate that while it cannot be confirmed, it is unlikely that the cook device caused or contributed to the patient's death.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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