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THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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| Model Number 102953 |
| Device Problems
Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Anemia (1706); Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440); Renal Impairment (4499)
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| Event Date 01/07/2021 |
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Event Type
Injury
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Event Description
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Related manufacturer¿s report # 3003752502-2021-00003.It was reported that the patient had blood loss anemia.Due to this, the patient was transfused with 6 units of reagent red blood cells, 3 units of fresh frozen plasma, 2 units of platelets and 20 cryo intraoperatively.The patient's chest was left open and the patient was brought back to the operating room for chest closure on (b)(6) 2021.The patient also had renal dysfunction with acute kidney injury post operation.The patient was placed on continuous renal replacement therapy (crrt).The patient had their arterial extracorporeal membrane oxygenation (ecmo) cannula in the right femoral artery with distal reperfusion catheter in place.The patient arrived to the intensive care unit (icu) with mottled right foot, unable to obtain pedal pulses.Popliteal pulses present.On (b)(6) 2021 the patient was taken back to the operating room for removal of ecmo cannulation from right iliofemoral arteries, thrombectomy of right common femoral, proximal profunda, superficial femoral and popliteal arteries and four compartment of fasciotomies of right calf.The patient had their chest closed on (b)(6) 2021.The patient had combined blood loss anemia from cardiac surgeries and additional surgeries requiring vascular surgery to lower extremity and laparotomy.The patient had worsening hemodynamic decompensation.A ct scan was obtained showing free intraperitoneal air concerning for bowel ischemia.The patient was taken of an emergent laparotomy.The patient had an infarction of the majority of the small bowel and right colon, which was resected and left in discontinuity for a second look surgery planned for (b)(6) 2021.A ct scan showed patency of the superior mesenteric artery out to the distal branching, then becomes difficult to visualize branches.Also showed an embolization to the liver and kidneys suggestive of a diffuse embolic event.This patient appears to have suffered a combined embolic and low flow insult to the bowel.The patient had acute liver injury related to shock versus ischemic damage with right hemiliver infarct noted on the ct.Liver enzymes and the patient's inr remained elevated despite the fresh frozen plasma administration.The patient was on antibiotic therapy due to positive bacterial blood cultures and endocarditis preoperatively.The patient was taken for a laparotomy on (b)(6) 2021.Peritoneal fluid grew candida albicans and 1 of 2 blood culture bottles also grew candida albicans.The patient started on antigungal therapy.The patient had repeat cultures drawn on (b)(6) 2021.The patient was taken back to the operating room on (b)(6) 2021 for extended ileostomy.The patient was taken back to the operating room on (b)(6) 2021 for re-exploratory laparotomy, ileostomy creation and cholecystostomy tube placement.On (b)(6) 2021 the patient experienced bleeding from oropharyngeal site, ears, nose and throat specialist was consulted and packing was placed.As of (b)(6) 2021, the patient received a total of 32 units of red blood cells and 13 units of platelets since initial surgery.During the initial surgery the patient had respiratory and metabolic acidosis and was placed on veno-venous (vv) ecmo and converted to veno-veno-arterial (vv-a) ecmo prior to leaving the operating room.The patient was unable to be extubated due to elevated inr tracheostomy was not placed.On (b)(6) 2021 the patient was taken to the operating room for ecmo conversion from veno-arterial (va) ecmo to vv ecmo.The patient required some respiratory support with carbon dioxide elimination.There was also a clot noted in the top perimeter of the oxygenator.
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Event Description
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It was reported that on (b)(6) 2021 bile drain had glycopeptide-resistant enterococcus and stenotrophomonas maltophilia and on (b)(6) 2021 cultures grew pseudomonas putida and stenotrophomonas maltophilia.On (b)(6) 2021, there was concern for possible pneumonia on chest x-ray.Computed tomography showed unchanged right and left pleural effusions.Tracheal aspirate grew stenotrophomonas maltophilia.Infectious diseases was consulted and it was recommended to hold off on broadening antibiotics pending tapping of pleural effusions.Chest tube placed cultures were negative to date and infectious diseases recommended not to treat due to negative cultures.
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Event Description
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It was reported the patient had gallbladder drain exchange and gallbladder stone removal on (b)(6) 2021.
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Manufacturer Narrative
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Section d4: the device serial number was requested but not provided.Manufacturer's investigation conclusion: a direct correlation between the reported events and the centrimag device could not be conclusively established through this evaluation.Additionally, a specific cause for the reported infection could not be conclusively determined.The centrimag will reportedly not be returned for evaluation.No further issues have been reported at this time.The centrimag blood pump instructions for use (ifu) (rev.09) lists bleeding, arterial non-cns thromboembolism, renal dysfunction, hepatic dysfunction, infection, and respiratory failure as adverse events that may be associated with the centrimag circulatory support system under ¿adverse events¿.This ifu also provides the following warnings and cautions: ifu warning #7: it is intended that systemic anticoagulation be utilized while this device is in use.Anticoagulation levels should be determined by the physician based on risks and benefits to the patient.Ifu warning #10: frequent patient and device monitoring is recommended.Ifu warning #21: use of the pump for periods longer than 30 days may result in pump failure, reduced pumping capacity, excessive blood trauma, and/or degradation of blood contact materials (with possible particles passing through the cannulae to the patient), leaks, and increased potential for gaseous emboli.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #9: monitor carefully for any signs of occlusion throughout the circuit.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.No further information was provided.The manufacturer is closing the file on this event.
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Event Description
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It was reported that the patient had respiratory failure beginning (b)(6) 2021 and weaning from vv ecmo support was attempted on (b)(6) 2021.On (b)(6) 2021, increased right pleural effusion was noted and the patient was placed back on vent all day on (b)(6) 2021.On (b)(6) 2021, a chest tube was placed and the patient was tolerating trials on high humidity trach collar well.On (b)(6) 2021, repeat cultures were taken and there was no growth.On (b)(6) 2021, a ct scan noted right paracolic gutter fluid collection and a drain was placed on (b)(6) 2021.Fluid was cultured and there was no growth.On (b)(6) 2021, the patient experienced bleeding and a drop in hgb from 8.4 to 7.4 overnight with blood loss from fasciotomy.2 units of red blood cells were given and the area of concern was cauterized.Bleeding resolved (b)(6) 2021.
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Event Description
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The site reported that the patient had bleeding around hemodialysis catheter site on (b)(6) 2021.They were taken to the operating room and given lidocaine and epinephrine injection, purse string suture placement and quick clot placement.Bleeding resolved on (b)(6) 2021.The patient¿s colectomy complicated by cholecystitis cholecystostomy placed on (b)(6) 2021.Patient on broad antimicrobial and antifungal coverage.Cholecystostomy tube exchanged on (b)(6) 2021.On (b)(6) 2021, the tracheostomy was capped and on (b)(6) 2021, the tracheostomy was decannulated.
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Event Description
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It was reported the patient was taken off ventilation on (b)(6) 2021 and their tracheostomy was capped on (b)(6) 2021.On (b)(6) 2021, the patient returned to the operating room for skin grafting of right leg.Medial fasciotomy wound and debridement of right leg lateral fasciotomy wound and application of wound vac.The left thigh skin graft placement to medial fasciotomy and wound vac placement to both medial and lateral fasciotomy sites.Patient was transfused two units of red blood cells post-op for blood-loss anemia.On (b)(6) 2021 the patient was taken back to the operating room for lateral fasciotomy graft, groin wound partial closure and wound vac removal of medial fasciotomy.Patient was given two units red blood cells post-op.The patient experienced arterial non-cns thromboembolism due to bowel resection, and patient developed short gut syndrome.On (b)(6) 2021, groin wound cultures and right leg wound cultures from the fasciotomy site were growing stenotrophomonas.The infectious diseases department was consulted and the patient was started on minocycline.On (b)(6) 2021, the patient experienced lethargy and was placed back on minimal ventilation support.
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