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Model Number 001-3300-011
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Adult Respiratory Distress Syndrome (1696)
Event Date 03/07/2021
Event Type  Death  
Event Description
A (b)(6) year-old prnhx of obesity initially visited another acute care facility on (b)(6) 2021 for sob but discharged to home the same day. Came back on (b)(6) 2021 for worsening respiratory failure requiring bipap and noted to be positive for covid. Patient started on steroids and rerndesivir. Rerndesivir d/cd after three days due to worsening aki. On (b)(6) the patient developed worsening hypoxia and was intubated. On (b)(6) 2021 he was transferred to (b)(6) for ecmo. Was implanted on (b)(6). Course complicated by ecoli pna. He was prone with initial improvement in oxygenation but worsened with abg 7. 29/58/58. Right ij and right femoral cannulas were placed, and he was started on vv ecmo on (b)(6) 2021. Worsening hypoxia on (b)(6), nitric oxide (ino) started. (b)(6) 2021 0510 perf. Note rounding & oxygenator sighed. On (b)(6) 2021 (b)(6) rn note. While being suctioned, pt coughed and there was a vagal episode where the pt's hr dropped to 32/min and flows on ecmo dropped to 1 liter per minute (lpm). Event spontaneously corrected and flows returned to 5. 5-5. 6lpm. On (b)(6) 2021 805 rn note - i was alerted to a malfunction of the breethe ecmo device controller screen went blank. Upon arriving at room at 805 am, i observed a dark blank screen. There was no indication of the device operating. The patient cardiac monitor revealed dropping spo2 from 93% going down gradually. Another rn followed protocol and removed the oxygenator and put it onto hand crank and the device was cranked to 4000 rpm. The spo2 stabilized and returned to previous levels. At 806 am the perfusion tech called and made aware. She arrived at bedside within 1 minute. The device was turned off and back on and it rebooted, and speeds were put on 3900 rpm. Perfusion tech at bedside managing restoration of perfusion. There were no injuries to the patient noted. On( b)(6) 2021 0806 perf. Note; at or around 0806, i received a call on house phone 71734 from 4pw that the breethe console display screen is black, please come right away. The rpm/flow of this patient during my 8am rounding was 3900/5. 6 lpm. At or around 0808, i arrived to patient's room and the patient's ecmo support was being provided by handcranking and the rn was at console, he told me he turned the console off then turned it back on again. I noted the console was indicating error "low flow alarm" and "air bubble detected" also revolution per minutes (rpm) were set at 3900. I dropped the rpm to zero, hand cranking stopped, both lines clamped, sterile pump lung unit (plu) placed back into pump driver, checked for air bubbles (none noted), rpm now set to 1500, clamps released, flow initiated and rpm raised to 3900. Approximate time ecmo support was initiated 0809. The blue battery light was continuously lit. Perfusionist leadership and breethe rep notified. On (b)(6) 2021 at 1329 md note: vy ecmo day 11 3900 rpm flow 5. 7l sweep 6 fio2 100%. A technical problem with the machine caused it to shut off this morning, with desaturation to the 70's. The manual crank was used, and the machine was rebooted and became functional again. Vent rr 16 pcv with peak 34 peep 12 for driving pressure 22 100% on ino 25. Abg 7. 34/42/61 89%. Creatinine 2. 0, stable since yesterday and down from peak of 5. 2 on (b)(6). On (b)(6) 2021 at 1613 mo note: continue fentanyl, versed, ketamine, propofol for sedation will wean. Nimbex for paralysis, will wean as tolerated. On (b)(6) 2021 0500 perf. Note: oxygenator sighed and visually inspected during the morning turn. On (b)(6) 2021 0810 rn note: upon report from the prior nurse, the sweep was viewed at 7, now the sweep is viewed at 6. 5 without anyone changing the setting. The sweep was put back at 7 and will closely monitor. On (b)(6) 2021 at 0938 rn note: the sweep again is viewed at 6. 5, will put back to 7, perfusionist notified. On (b)(6) 2021 0943 rn note; received the patient sedated and paralyzed, the train of four (tof) is 4/4, not breathing above the vent settings, pulling tidal volumes of 140 ml, pupils arc 2mm and brisk, ecmo via the right internal jugular vein (ijv) and right groin with intact dressings, on flo2 100, sweep 7, rpm 3900 and 5. 6-5. 7llters. On nimbex, versed, fentanyl, ketamine, heparin, and propofol drips, nitric oxide at 25ppm. On (b)(6) 2021 1302 rn note: heart rate is up to 122, sats arc 84. Bolused with versed and fentanyl. On (b)(6) 2021 at 1339 md note: acute hypoxic respiratory failure secondary to ards and aspiration pna: vv ecmo-4l00rpmsweep 8, 6lpm flow, 100%; ino 25ppm, 100%/pc22/16/12 peak 35, plat 33, sputum culture growing e. Coli and pseudomonas- on meropenem day 7; abg showingpo2 54 on 100%, continue solumedrol 20mg daily for 3 days, will decrease to 10mg from tomorrow. On (b)(6) 2021 1853 apn note: spoke to the patient's father. Discussion or current clinical status--> desat today to 80s, settings increased on ecmo, bronch today for hypoxia, continue merrem for pna, on (b)(6) 2021 at 1900 rn note: there have not been any issues since this am or the sweep moving on its own. Sats arc up to 85, report to night rn. On (b)(6) 2021 perf note: breethe oxygenator sighed externally and internally. On (b)(6) 2021 0900: rn note: pt. O2 sat 79-80%. Pt on 100% peep of 12 and nitric. Vv ecmo 100% sweep of 8. Md made aware of o2 sat. On (b)(6) 2021 at 0932 rn note: abgshowingpo2 60. 6 on 100%. On (b)(6) 2021 at 1120 rn note: vv ecmo day 13 4050 rpm flow 5. 9l sweep 8 fio2 100%. Vent rr 16 pcv with peak 34 peep 12 for driving pressure 22 100% on ino 25. Abg 7. 30/37/61 88%tv 130 for compliance. On (b)(6) 2021 1123 apn note: spoke to patient's father. Discussion of current clinical status --> remains on mechanical ventilation, heavy sedation, ecmo, desat overnight w/ improvement after blood transfusion, elevated liver enzymes for ruq u/s today. Aware overall prognosis is poor, at this time would like to continue aggressive medical care. He and his wife will visit at bedside tomorrow. On (b)(6) 2021 1015 perf. Note: i drew pre and post oxygenator samples as per cardiac surgeon request. Oxygenator sighed after samples were drawn. Results: pre oxygenator, 7. 27/40/47/80%sat, post oxygenator: 7. 31 /34/319/99%sat. Md made aware. On (b)(6) 2021 at 2134 md note: a single frontal view of the chest was obtained portably. Comparison is made prior film of (b)(6) cardiac size is at the upper limits of normal to borderline enlarged. Endotracheal tube, nasogastric tube, and bilateral central venous catheters arc seen in satisfactory positions. Lungs are 'hypocrated' with superimposed mild elevation of the left diaphragm. Diffuse bilateral infiltrates arc not appreciably changed. Trace effusion on the left. No pneumothorax. On (b)(6) 2021 1403 apn note, i met with the patient's mother, father, and 2 sisters in person today after they were able to sec the patient. I explained that the patient continues to require high amounts of support from both the ecmo and ventilator at this time. He continues to have multiorgan dysfunction including liver and kidney injury in addition to lung injury. I explained that his saturation remains in the low 80s despite this support. I explained that should he pull through this and get off of ecmo support, that he would likely require tracheostomy and peg tube placement and care in a long term care facility. The patient's mother and father expressed that the patient would never have wanted to live this way. They wished to continue aggressive treatment for now but understood that he may not improve. They wish to meet again later this week. On (b)(6) 2021: perf. Note - perf. Rounded this morning helped rn and found fibrin formation in the oxygenator. Ecmo parameters per event page. Heparin infusion at 1450 units and latest ptt 51. 6 sec. On (b)(6) 2021 at 1029 rn note: chattering noted in ecmo circuit. Md made aware. Giving albumin 12. 5g. Monitoring. Ecmo 100%/sweep 8/ rpm 4050/ flow 5. 8 5. 9. On (b)(6) 2021 1050 perf note: rounding at 1050, oxygenator sighed, visual flashlight check of circuit reveals slight white streaking on oxygenator. Oxygen saturation on monitor- 81%, pao2 decreasing, on (b)(6) 2021 1146 rn note: chattering noted in ecmo circuit. Md made aware. Giving 500 cc lr bolus. Sats 81%, hp on a down trend. Max ecmo and vent settings. On (b)(6) 2021 1720 apn note: i called the patient's father via phone today to update him regarding the patient's clinical condition. I explained that (b)(6) remains on maximal support on the ecmo as well as the ventilator. The father expressed that he would be holding a family meeting to discuss dnr/comfort status this weekend and would let us know what the family's decision would be. On (b)(6) 2021 2000 rn note: o2 sat79%. Hr 120's in st. Pt on vy ecmo 100%, sweep of 8 rpm 4050 with 5. 9 co. Ventilator at maximum support iao2 100%, peep+ 12 on pcv. On (b)(6) 2021 2030 rn note: pt hypotensive, sbp 80-90's. Levophed gtt started, sec doc flowsheet for vital sign trends, and titration. On (b)(6) 2021 0204 rn note: abg reviewed with apn. Ph 7. 1, pco2 43. 0, po2 42. 0, hco 15. 9, and 02 sat 72. 1. Sbp dropping despite levophed 50 mcg/min, sodium bicarbonate ivp given as ordered and vasopressin gtt started. On (b)(6) 2021 at 0215 rn note: pt progressively hypotensive, sbp 70-80's despite levophed and vasopressin gtt. Apn made aware. Neosynephrine gtt initiated. On (b)(6) 2021 at 0245 rn note: hr dropped to 100 from 130's. Bp progressively dropping despite levophed and vasopressin, and phenylephrine gtt max'ed out, apn made aware. Epinephrine gtt initiated and max'ed out, sec doc flowsheet for vital sign trends. Additional sodium bicarbonate ivp given as ordered. On (b)(6) 2021 0554 rn note: rn at pt's bedside administering dextrose 50% 50 ml, humulin r 5 units ivp, and sodium bicarbonate 50 mcg ivp for hypoglycemia. At 0601 02 sat alarmed 40%, looked over to breethe ecmo and console screen noted to be blank. Called for help. Additional staff to the bedside immediately. Perfusionist called to bedside emergently. Device confirmed to be plugged into red outlet. At 0602 device manually cranked by myself to achieve rpm of 4. 5. At 0603 breethe ecmo powered up and rebooted by another rn. Pt's hr 30-40, no pulse noted, code blue called at 0602 and code in progress. Breethe powered on and passed all self -checks, oximeter reattached to device, rpm's placed to previous settings and achieving a flow of 5. 8 at 0607. Icu team at bedside. On (b)(6) 2021: perf. Note: perf. Rounded this morning and oxygenator has some dots. Heparin infusion at 1450 units. Received a call at 06:01 from 4pw saying ecmo machine stopped and need help asap. Rushed to 4pw to support. By then rn tried to handcrank. We rebooted the device and resumed the support. Patient was pronounced at 06:12. The device involved in care of this patient is breethe (abiomed) s1#(b)(4). On (b)(6) 2021 at 0612 rn note: md spoke to the family, as per family wishes, resuscitation terminated. Pt with no pulse and no spontaneous respirations. Pt pronounced by apn. Awaiting family arrival to view patient. On (b)(6) 2021 discharge summary: overnight on (b)(6) patient became more hypotensive requiring increasing vasopressors. At 0601, patient suffered cardiac arrest. Cpr was initiated and family called. Family requested cpr to be stopped and patient was pronounced deceased at 0612 on (b)(6) 2021.
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Type of DeviceECMO
Manufacturer (Section D)
22 cherry hill dr.
danvers MA 01923
MDR Report Key11559623
MDR Text Key242054574
Report Number11559623
Device Sequence Number1
Product Code DTZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number001-3300-011
Device Catalogue Number001-3300-011
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/19/2021
Distributor Facility Aware Date03/07/2021
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer03/19/2021
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/19/2021 Patient Sequence Number: 1
ABIOMED OXY-1 PUMP DRIVER REF# 001-0301-001, SERIAL NUMBER (B)(4), (B)(6) 2021-(B)(6) 2020 ; ABIOMED OXY-1 PUMP DRIVER: SN (B)(4), MFR DATE: 11/05/ 2020, (B)(6) 2021-(B)(6) 2020; ABIOMED BREETHE OXY-1 CONSOLE INTRAVASCULARLY