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In additional information received on 15jun2021, it was reported that the tunneled cvc was placed in the right chest of the patient on (b)(6) 2020 for the administration of blood components.On (b)(6) 2020, the patient received a 1l blood transfusion.Afterwards the nurse flushed the line with 20ml of saline.It was during flushing that the catheter broke and began leaking from the tubing on the blue side port between the injection port and clamp.The patient had to wait for an or, which was scheduled the following day on (b)(6) 2020.The leaking device was then replaced with catheter from another manufacturer.It was reported that the patient experienced extended hospitalization, psychosocial stress and scarring on the chest and neck due to this occurrence.Patient activity level was described as "active." the catheter was secured to the patient with tegaderm and gauze sponges.Saline was used to lock the catheter when not in use and tpn was being maintained by the caregiver at home.No difficulty was experienced when attaching or disconnecting ancillary devices to the complaint device.An official translation of a claim document was provided on (b)(6) 2021.The facility where the event occurred was lund university hospital, sct clinic.The patient had aplastic anemia and was scheduled to receive a stem cell transplantation via sibling donor."the patient had a cvc surgically inserted on (b)(6) 2020.On (b)(6) 2020, one of the tubes in the cvc burst after flushing with sodium chloride following 3 hours of blood transfusion.This was not noticed by the healthcare staff, but the patient noticed that his shirt had become wet and remarked that it felt like the hose was leaking.This occurred as the patient was on their way home and would then have continued with home care for 5 days.Two days before this happened, the date of the stem cell transplant was postponed by 6 days, with notification of this the day before admission.The anaesthetist wanted to remove the defective cvc after 6 hours of fasting at 19:00 on (b)(6) 2020 and then wait with continued fasting until 10:00 on (b)(6) 2020 before sedating the patient again to insert the new cvc.The patent has type 1 diabetes and is not able to fast for more than a day even if he has glucose drip.The doctor on duty was also unaware that the patient was on medication as a result of autoimmune liver hepatitis, including cortisone.If this had not been pointed out by us parents, the patient would not have been given his medicine during the fast.In the end, it was decided to wait overnight and anaesthetise august on (b)(6) 2020 to remove the cvc and put in a new one at the same time." the patient had not finished treatment and had not recovered at the time of the claim.Medical records were provided for the patient.The following are notes from the patient¿s consultations/care notes/supervising paediatrician notes/surgeon operative notes: date of consultation: (b)(6) 2020, 14:01.Consultant: doctor (b)(6) , haematological clinic sct lund (sctml).Notes: registered for donor search due to post hepatitis saa.Type 1 diabetes mellitus.Infected in (b)(6) 2019 with acute hepatitis.No infectious aetiology detected.Liver biopsy shows pronounced non-specific panlobular hepatitis.Antibody investigation negative.Treated with steroids with good effect.Around the turn of the year, blood values slowly deteriorated.In particular, increasing thrombocytopenia which is now below 10.Hb around 90.Neutrophil 0.6.Bone marrow biopsy shows picture consistent with aplastic anemia with bone marrow for cellularity below 25%.Has two siblings.Hla typing performed on the family.Date of consultation: (early hypotheses) (b)(6) 2020, 11:14.Consultant: doctor (b)(6) , haematological clinic sct lund (sctml).Notes: family typing has shown that the patient has an hla-identical brother in [xxx].The other brother is haploidentical.However, the hla-identical brother has some comorbidity and will now be initially assessed for donor suitability by independent paediatricians.Screening bmdw shows about 390 potential donors 18/8 typing.Date of consultation: (b)(6) 2020, 00:00.Consultant¿s note: doctor (b)(6) , haematological clinic sct lund (sctml).Notes: the patient¿s brother [xxx], who is hla-identical, has been deemed medically eligible for bone marrow donation to his brother with severe aplastic anemia.The case is now awaiting approval by the national board of health and welfare.Preliminarily planned bone marrow harvest of brother and tx wednesday (b)(6).Imaging and referrals were sent to cardiovascular and paediatric department for review and response.Date of consultation: (b)(6) 2020, 15:14.Consultant: doctor (b)(6) , department of paediatrics 64 lund consultation response: patient is thrombocytopenic and has a bleeding tendency.Patient to be transfused with irradiated blood products.Date of visit: (b)(6) 2020, 15:27.Consultant: doctor (b)(6) , department of paediatrics (b)(6) examination/treatment: checks: p-glucose once per hour until surgery, sampling: (b)(6) 2020, transfusion related cell count (trc) post-transfusion follow-up, x-ray cvc position ordered, cvc replacement ordered.X-ray: x-ray cvc position ordered.Treatment: cvc replacement ordered.Date of daily summary from supervising paediatrician: (b)(6) 2020, 15:34 doctor (b)(6) , department of paediatrics (b)(6).Current: ¿in brief, patient with post-hepatitis severe aplastic anemia (3-line bone marrow failure, transfusion-requiring anemia and thrombocytopenia) and diabetes.Will start conditioning for allogeneic bone marrow transplant on wednesday next week.Came in to outpatient clinic today for weekly checkup, transfused with 1 bag of blood.The cvc ¿popped¿ during infusion according to information from nurse lina, visible leakage (squirt) when trying to flush the cvc.Cvc clamped proximally around the hole patient in good condition, fever-free, no cough/sneeze, no diarrhea.Auscultation of the lungs nad inspection of the oral cavity nad abdominal palpation nad.Diabetes consultant contacted.Recommends following the same recommendations regarding the management of diabetes as in cvc insertion (see note by m.Elfving 05/03/2020).The patient is an emergency op notified for cvc replacement.Pvc inserted, trc transfusion and coagulation status checked prior to procedure.¿ date of doctor¿s notes: (b)(6) 2020.Reason for admission: unplanned, need to replace cvc due to puncture.Previous illness: diabetes mellitus type 1, pump-treated current disease: ¿came down with acute hepatitis and cholestasis with rising prothrombin complex (pc) and bilirubin in (b)(6) 2019.Transferred to huddinge due to liver failure (elevated pc).No infectious aetiology was detected.Liver biopsy performed at huddinge showed pronounced non-specific panlobular hepatitis.Started on prednisolone treatment as with autoimmune hepatitis, although neither the histological picture nor antibody analysis was consistent with the diagnosis.Relatively rapid improvement of liver tests.Since the end of (b)(6) 2019, tendency to degradation in blood tests, especially platelets, and also to some extent white blood cells.Bm examination (b)(6) 2020 shows hypoplastic bone marrow on both smears and biopsy with very low cell density, <25%.No sign of dysplasia results of fanconi anemia investigation not yet available.Thus picture as in aplastic anemia.Classified as saa.Hla-identical sibling identified in older brother 051016-0211.Under current donation investigation.If approved, intended conditioning with cyclophosphamide 200 mg/kg + atg, and csa/mtx gvh prophylaxis¿ current: came in to sct outpatient ward today for blood status check and information consultation about the change in plans (bone marrow to be harvested in advance and cryopreserved due to the covid pandemic.Father was informed yesterday by phone).The boy is in good general condition, without fever and no ongoing bleeding.We will discuss the decision with the family.The mother is worried that this will not impair patient's chances of being cured.I explain that we always try to transplant fresh stem cells and with allogeneic stem cell transplantation, because freezing cells constitutes a risk factor where the cells could possibly be damaged, plus infusion of thawed cells can be more complicated and have a greater risk of side effects.However, we have no evidence to suggest that cryopreservation of the cells would impair the long-term outcome of bone marrow transplantation.Due to the current pandemic, a strong recommendation from the european bone marrow transplant group and following discussion within the swedish bone marrow group (dr (b)(6) ), we believe that this will be the safest way to perform bone marrow transplantation.The parents accept this decision.The patient receives 1 bag of blood due to the haemoglobin case, although the platelet count is at 13, thus no platelet transfusion would be performed.After transfusion, when flushing the lumen, a hole was found in the cvc tube (the blue cork).Therefore, the cvc must be replaced.Current medications: tablet esomeprazole 20 mg 1 x 1, tablet ursofalk 500 mg 0.5 tablet x 2 tablet prednisolone 5 mg 1 x 1, insulin according to specific prescription general condition: good general condition.Unhappy because he had to be admitted.Oral cavity and pharynx: no irritation.Lungs: auscultated bilaterally nad.Abdomen: palpitated nad.Evaluation: patient has to be admitted due to a punctured cvc tube.Op is urgently notified for cvc replacement fasting from 13:00.Coagulation status is acutely controlled, thrombocyte transfusion is also prescribed.The anesthetist in charge of the operation is contacted.Date of care note: (b)(6) 2020, 19:50.Care provider: (b)(6) , department of paediatrics (b)(6).Note: pm: admitted from sct due to ruptured cvc, see doctor¿s note.Planned for cvc out and new cvc in.Signed nurse (b)(6).Information/training: pm: long conversation with paediatric oncologist and anesthesiologist regarding planning as op is not able to insert cvc tonight, removal only.The parents are opposed to this as it involves two anesthetics, and want both the removal and the insertion to be done under the same anesthetic after discussion with anesthetist, a solution emerges where all procedures are scheduled for tomorrow.Signed nurse (b)(6).Circulation: pm: the anesthetist flushes the cvc lumen to check whether both are broken.Red lumen works, but when flushing the blue lumen it squirts from the cvc.On the recommendation of the anesthetist, tegaderm is placed over the area with the hole and adhesive tape used to mark the lumen that is broken.Signed nurse (b)(6) medication management: pm: according to his father, he should have ursofalk.Calls oncologist on-call (b)(6) who prescribes t.Ursofalk 500mg 0.5 by telephone, according to previous prescription from visit to outpatient ward.Signed nurse (b)(6) planned procedures: op tomorrow: removal of old cvc and insertion of new cvc.Fasting from 02.Has to have ivs during fasting because of his diabetes.Capillary blood sugar checks before fasting and once/hour during the drip until anaesthetic, see doctor¿s note (b)(6) 2020 and endocrinologist¿s note (b)(6) 2020.Will also have thrombocyte transfusion before surgery.Date of post operative nurse note: (b)(6) 2021, 13:34.Care provider: nurse (b)(6) operational measure: cvc out right side.New tunneled cvc in left side information: dr.(b)(6) has looked in and talked to patient and patient¿s father.Circulation: post-op checks nad.Received a single dose of antibiotics peroperatively.Received thrombocytes peroperatively.Heparin lock in both vessels, applied peroperatively.Breathing: post-op checks nad.Bandages: bandage on right side of chest has a little light fluid in the middle.Dressing on side of chest near cvc looks fine on arrival, leakage at side of dressing is discovered after a period in postop, reinforced with new tegaderm.Bandage on left side of neck has light pink spot in the middle.Pain: received paracetamol, morphine and local anesthetic peroperatively.Denies pain, flacc 0 nutrition: received ondansetron peroperatively.Plasmalyte 5% with additional p-gluc at 35 ml/h from dept.P-glucose in postop 8.3-9.9 digitally.Checking p-glucose with prick in toe showed 9.0 mmol.When the digital meter pointer showed 9.9mmol, the father was happy with that.Does not want anything from us, waiting for mcdonalds when patient gets to the ward.Sleep: sleeps peacefully, wakes up peacefully.Miscellaneous: pulmonary x-ray performed in postop at 13.50.Dr.(b)(6) x-ray images, nad.Return to ward 64 at: 14.15 date of surgical note for cvc insertion: (b)(6) 2020, 13:52.Surgeon: dr.(b)(6) , paediatric intensive care unit lund indication for cvc: vascular drugs, ongoing anti-coagulant treatment, procoagulants before admission.Time of insertion: (b)(6) 2020 12:53.Place of insertion: operating room.Location: left internal jugular vein.Insertion method: ultrasound, real-time, out-of-plane.Catheter position in the skin: read centimeter mark hole suture over cuff.Will stay in place.Single sutures on the skin and over the insert, which can be removed after 10 days.Anaesthesia method: general anaesthesia.Position check and use: ultrasound at insertion.Transillumination at insertion.X-ray after insertion.May be used immediately.Product facts: 2 lumen manufacturer: vygon model: lifecath biflux lot/batch: 250219gg 7.0 french complication at insertion: no suspected complication.Bleeding during cvc insertion: no bleeding requiring action.Number of punctures through the skin 1.Number of vascular punctures 1.Procedure code: sp212 insertion of central venous catheter, multi-lumen, into internal jugular vein, tunneled.Date of cvc catheter care note: (b)(6) 2021, 11:39.Care provider: nurse (b)(6) , department of paediatrics 64 lund.Inspection performed: (b)(6) 2020, washed away blood that appeared after insertion, coagulation at insertion that cannot be removed.Signed nurse (b)(6) realignment performed: (b)(6) 2020, washed with chlorhexidine, steristrip, compresses, cavilon, iv3000.Signed nurse (b)(6).Date of care note: (b)(6) 2021, 14:01.Care provider: nurse (b)(6) , department of paediatrics 64 lund.Circluation: am: connected prescribed drip during boy¿s fast.Monitored blood sugar.High 15.1 at 09.Reduced the drip rate to half as prescribed.Signed nurse (b)(6) blood transfusion: (b)(6) 2020 one unit thrombocyte (trc) during the morning.Connected a unit of trc before the boy was wheeled up to op.Signed nurse (b)(6).Skin/tissue: pm: bleeding after cvc insertion.Changed the bandage on the neck, looks good.Reinforced dressing at the stitching point in op.The bandages were not saturated.Three 92 should stop soon.Signed cm psychosocial: pm: afraid to use his cvc.Worried that it will hurt.Signed cm.Date of daily summary from supervising paediatrician: (b)(6) 2020, 15:44.Doctor (b)(6) , department of paediatrics 64 lund.Current: patient admitted yesterday for replacement of punctured cvc.Initial plan was to perform cvc replacement last night.Unfortunately, due to staff shortages, only the removal of the malfunctioning cvc under short-term sedation with propofol could be offered yesterday, while the insertion of a new cvc was to be done today.However, this would mean two anesthetics and two fasting periods, which is stressful for the patient due to diabetes.The patient was informed yesterday by the undersigned, together with anesthetist dr (b)(6) , that it was not possible to perform both procedures in one session.The parents were very upset and categorically refused to accept two anesthetics.After a while, the undersigned met with the parents again, together with anesthesiologist dr (b)(6).Dr (b)(6) examined the punctured cvc and judged that it was safe to temporarily secure the cvc with tegaderm and perform both procedures in one session today.This solution was accepted by the parents.Today the cvc exchange has been performed, without complications.At the time of dictation there is no recorded response to the pulmonary x-ray check.The parents have been informed, if i understand correctly, by the anesthetist that the pulmonary x-ray shows no abnormalities.The patient should stay in hospital until tomorrow morning, if no delayed bleeding occurs, the patient can be discharged home.To be readmitted on tuesday next week.Referral for abdominal ultrasound + elastography of the liver recorded.¿ date of care note: (b)(6) 2020, 11:36.Care provider: care provider: nurse (b)(6) , department of paediatrics 64 lund.Skin/tissue: am: reinsertion of cvc.Signed nurse (b)(6).Planned procedures: am: father informed to contact the department if bleeding from cvc insertion occurs.Then the family goes home, back on tuesday for conditioning start.Signed nurse (b)(6).Supervising doctor¿s note dated (b)(6) 2020, 13:12.Doctor (b)(6) , department of paediatrics 64 lund.Current: feeling well today.Discharged in good condition.A request for image and function for an ultrasound was made by doctor (b)(6) , department of paediatrics 64 lund on (b)(6) 2020, 11:50.The request was made by the liver team in huddinge for a baseline position before allogenic bone marrow transplant.Medical history provided with the request: patient with post-hepatitis severe aplastic anemia who begins conditioning on (b)(6) for allogenous bmt with sibling donor.Has been admitted with liver failure in huddinge, but responded well to steroid treatment, now normalized liver tests.Huddinge wishes to perform ultrasound of the liver with elastography to have a baseline picture and to be able to follow the evolution after bmt.Note! patient has diabetes.A response to the request for image and function from dr.(b)(6) for the ultrasound was received on (b)(6) 2020, 00:00.The exam was completed on (b)(6) 2020.Dr.(b)(6) response: ¿ultrasound liver, for comparison, ultrasound abdomen (b)(6) 2019 is used.The liver is normal size with slightly high and slightly variable ecogenicity.No focal clearly demarcated change.Irregular liver spots.No biliary dilatation intra- or extrahepatically.The gallbladder has essentially returned to normal.No concretion in the gallbladder.Elastography examination performed with 8 measurements craniolaterally in the right liver lobe with the patient in the left lateral recumbent position.Median value 8.1 kpa [iqr 1.8].This measurement was made with the paediatric abdomen and pelvis protocol, which can generally give higher values than the abdomen and pelvis protocol.Note that reference values for children have not yet been established, but the value is suggested to be high compared to the normal range for adults.Evaluation: holding points for residual liver impact¿ additional information to supplement the previously stated final answer was provided by dr.(b)(6) on (b)(6) 2020.¿(b)(6) 2020 ultrasound liver with elastography.Normal flow profiles in portal veins and hepatic veins.Otherwise see below.(b)(6) 2020 ultrasound liver with elastography for comparison, ultrasound abdomen (b)(6) 2019 is used.The liver is normal size with slightly high and slightly variable ecogenicity.No focal clearly demarcated change.Irregular liver spots.No biliary dilatation intra- or extrahepatically.The gallbladder has essentially returned to normal.No concretion in the gallbladder.Elastography examination performed with 8 measurements craniolaterally in the right liver lobe with the patient in the left lateral recumbent position.Median value 8.1 kpa [iqr 1.8].This measurement was made with the paediatric abdomen and pelvis protocol, which can generally give higher values than the abdomen and pelvis protocol.Note that reference values for children have not yet been established, but the value is suggested to be high compared to the normal range for adults.Evaluation: holding points for residual liver impact.¿ a request for image and function for a bedside x-ray was made by doctor (b)(6) , department of paediatrics 64 lund on (b)(6) 2020 to confirm cvc position after replacement.The signing physician¿s name is illegible.However, a response to the request was provided on (b)(6) 2020, 13:57.¿(b)(6) 2020 13:57 x-ray lung examination in supine position.Since pulmonary x-ray (b)(6) 2020, the right-sided cvc has been removed and a new left-sided cvc has been inserted.Catheter tip at the site of the right atrium.No pneumo or hemothorax.The earlier retrocardiac lamellar atelectasma on the left side have diminished and new perihilar thickenings have appeared on the left side and medially apically on the right side.Photos of the patient¿s neck and chest were provided with areas of scarring circled.Lab values from testing on the following dates were provided: (b)(6) 2020.Current prescriptions from medical records dated (b)(6) 2020: esomeprazol, 20 mg, one tablet twice per day.Ursofalk® oral suspension, 50 mg/ml , 5ml twice per day.Insulin lispro sanofi solution for injection, 100 units/ml, once per day in the evening novorapid® penfilt® solution for injection in a cylinder ampule 100 e/ml ,once per day in the evening.Insulatard® flexpen® solution for injection, suspension in pre-filled injection pen 100 le/ml , once per day in the evening.Levemir injection, 100 e/ml , once per day in the evening.Emgesan® tablet , 250 mg, daily.Glucagon, powder injected 1 mg (1 iu) , daily.Meropenem, 50 mg/ml, 4 times per day for 14 days.Bactrim oral solution, solution 40 mg/ml + b mg/ml , 10mg twice per day.Caspofungin, 0.5 mg/ml, 120 ml, once per day.Valaddovir , 250 mg, one tablet twice per day.Ntvestim injection 30 me/0.5 ml, 0.3ml once per day.Tacrollmus 1 mg capsule, once per day.Levetiracelam accord oral solution 100 mg/ml, 5ml twice per day.Midazolam inf/inj.1 mg/ml , 1 mg once per day in the evening.Thrombocytes, 1 unit as needed per day.Erythrocytes, 1 unit as needed per day.Fiasp solution for injection 1 ampule 100 units/ml , 5 units as needed per day.Glucose baxter viaflo infusion fluid, solution 50 mg/ml , 100 mg as needed per day.Plasmalyte infusion fluid, 1000 ml as needed per day.Potassium chloride 2 mmo/ml, for addition to infusion solution, as needed per day.Furosemide, injection, 10 mg/ml, 1.8ml, as needed per day.Alvedon® film-coated tablet 500 mg, 1 tablet as needed per day.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.A swedish claim from a national insurance body was reported to cook stating that a redo double lumen tpn catheter set (rpn: c-tpns-5.0d-65-12-redo, lot number 9545988) broke, causing psychological stress to the patient, who was a 10-year-old boy diagnosed with diabetes mellitus type one (pump treated), aplastic anemia, autoimmune liver hepatitis, and thrombocytopenia.The patient was scheduled to receive a stem cell transplantation via a sibling donor due to their aplastic anemia.The patient had a central venous catheter (cvc) surgically inserted on (b)(6) 2020 on his right side.On (b)(6) 2020, the stem cell transplant was postponed six days (reason unknown).On (b)(6) 2020, one of the tubes in the cvc burst after flushing it with 20 ml of sodium chloride.The flushing occurred after a blood transfusion (one liter) that infused over three hours.The ¿burst¿ was not noticed by the healthcare staff- the patient noticed that his shirt had become wet and remarked that it felt like the hose was leaking.The leaking occurred before the patient left the facility where the transfusion was taking place.The red lumen of the device was reported to be functional.However, when flushing the blue lumen of the device, leaking was noted.Tegaderm was placed over the area of the hole and adhesive tape was used to mark the broke (blue) lumen.Before the discovery of the device leaking, the patient¿s care plan was to return home; however, due to the device leak, the patient had to be hospitalized.The anesthetist wanted to remove the defective cvc after six hours of fasting at 19:00 on (b)(6) 2020.The anesthetist also wanted the patient to fast until 10:00 on (b)(6) 2020 and then a new cvc would be inserted.The claim reported that as the patient is a type 1 diabetic, they are unable to fast for more than a day even if a glucose drip is administered.It was decided to wait overnight and anaesthetize the patient on (b)(6) 2020 to remove the cvc and place a new cvc in one procedure.A new tunneled cvc (vygon) was placed in the left internal jugular vein using ultrasound.Single sutures were placed on the skin and over the insert.Sutures were ordered to be removed after 10 days.X-ray was completed after insertion of the new device and it was reported that the new device could be used immediately.Imaging for post-cvc placement reported the following: ¿x-ray lung examination in supine position.Since pulmonary x-ray (b)(6) 2020, the right-sided cvc has been removed and a new left-sided cvc has been inserted.Catheter tip at the site of the right atrium.No pneumo or hemothorax.The earlier retrocardiac lamellar atelectasma on the left side have diminished and new perihilar thickenings have appeared on the left side and medially apically on the right side.¿ the patient had the dressing changed on the new cvc (vygon) the next day and a needleless connector (cavilon iv3000) placed on the end of the device.They were discharged from the hospital on (b)(6) 2020 and expected to return the next week to continue treatment.Photos of the patient¿s neck and chest were submitted depicting scarring.At the time of the claim, the patient had not finished treatment and had not recovered.A review of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures 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 dhr for the reported complaint device lot (9545988) and the related catheter subassembly lot revealed no recorded non-conformances.A database search did not identify any other events associated with the device lot.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints have been received from the field, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The tpn catheter set was supplied with ifu c_t_tpn_rev7, which includes the following in relation to the reported failure mode: ¿warnings ¿ if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify the attending physician immediately.Precautions ¿ silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10 ml syringe or larger will reduce the risk of catheter rupture.Suggested catheter maintenance if catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with heparinized saline solution.Normal saline lock is permissible if utilizing the clc2000 injection cap.Catheter heparinization should be determined by institutional protocol and clinical judgement.Heparin concentrations of 10 units/ml to 100 units/ml have been reported adequate to maintain lumen patency.Catheter lock should be reestablished after every use or at least every 24 hours if unused.Before using catheter lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between administration of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin or saline lock.¿ based on the information provided, no product returned, and the results of our investigation, a definitive root cause was unable to be established.Based on the available evidence, it was not possible to rule out device maintenance/care or inadvertent tension as possible causes.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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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