MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L XTRA CELL SAVER; APPARATUS, AUTOTRANSFUSION

Device Problem Inadequate Instructions for Healthcare Professional (1319)

Patient Problems Pulmonary Embolism (1498); Hemorrhage/Bleeding (1888); Cognitive Changes (2551); Aspiration Pneumonitis (4455); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/02/2021

Event Type  Death  

Event Description

Cell saver devices are utilized to harvest blood loss that is incurred from surgical intervention.The blood is "washed", reprocessed, and concentrated to produce fluid that has a higher than physiologic hematocrit.This blood product can be utilized to transfuse patients during surgical intervention to save their own blood, and potentially, mitigate the need for allogeneic blood transfusion.In lower doses that do not exceed approximately 500 cc, in my experience, the use of this technology can be very helpful during spine surgery.It is my understanding that other surgical disciplines utilize the cell saver or equivalent devices.However, the device manufacturers of these companies do not identify any problems or contraindications for the use of this technology.The product handbook simply does not identify any pitfalls associated with the use of reprocess shed blood.The problem with the exuberant use of shed blood that is reprocessed in such a manner is that it is devoid of coagulation factors, and the ongoing transfusion of this reprocessed blood can produce and promulgate coagulopathies which, in turn, creates accelerated blood loss, and a perceived need for more blood transfusion.The proper management of blood loss at this point is not discussed in the handbook that is produced by the various manufacturers that produce these blood transfusion devices.This can create a catastrophe, particularly when the anesthesiologist utilizes phenylephrine and other vasopressors in lieu of appropriate allogeneic blood and coagulation product transfusion in a timely fashion.Further, the reprocessed blood may be contaminated with carboxyhemoglobin from carbon monoxide exposure from electrocautery of bleeding tissues.This will give the anesthesiologist and others who are involved in the care of patients the false impression that there is an adequate hemoglobin oxygen saturation unless the anesthesiologist is astute enough to check a timely carboxyhemoglobin.In the case of concern, as well as other cases that i have observed over the years, there is not the appropriate use of the cell saver type devices on a routine basis at deaconess medical center in spokane, washington.This introduces substantial problems with bigger surgical cases that cannot be performed utilizing minimally invasive technology.In the case of hm, the use of the cell saver product resulted in a coagulopathy, more blood loss than i would normally incur in such a spine case, hypoperfusion of end organs, and likely, conversion of the patient's low-level dementia to a full-blown delirium that led to multiple episodes of aspiration pneumonia, pulmonary embolism, and death by "aspiration pneumonitis".As noted in a prior complaint, this may have been exacerbated by using phenylephrine, a vasopressor, in conjunction with the cell saver product, thus exacerbating the resulting low brain blood perfusion and oxygen availability to the end organs.It is recognized that the use of cell saver for ultimate transfusion amounts that do not exceed 500 cc can be very beneficial for patients, however there is no advice from the manufactures associated with intraoperative cell saving about the proper use of this device and the contraindications associated with the use of the device.Based upon my experience with the use of cell saver over the course of more than 15 years, it has been my observation that the maximum threshold for use of the cell saver product should be 500 cc or less.Even after 250 cc of transfusion, coagulation studies that include pt/inr, fibrinogen, and ptt should be obtained, and anecdotally, it has been identified that these can be abnormal even after only 250 cc of cell saver transfusion.Further, there should be proper general anesthesia management of patients who are candidates for the use of cell saver by virtue of the magnitude of the surgery.Specifically, the anesthesiologist of concern should utilize an arterial line, potentially a central line, routine periodic arterial blood gases, lactic acid levels, and obsessive fluid accounting.This is not occurring at deaconess medical center in spokane, washington, however the proper use as such is not stipulated by the manufacturer of the cell saver-like devices, and this is threatening my patients who have intermediate to larger cases.Instead, the appearance is that anesthesia often utilizes the cell saver and vasopressors as a proxy for maintaining proper blood pressure during anesthetic cases in lieu of proper blood and coagulation supplementation.I believe that it would be proper for the manufacturers of the shed blood reprocessing companies to stipulate this in their handbook.Please review this matter promptly as this has immediate patient outcome implications, and the lack of doing so is resulting in compromised patient outcomes in intermediate to larger cases that require open surgical intervention.Event abated after use stopped or dose reduced? no.Fda safety report id # (b)(4).

• Brand Name: XTRA CELL SAVER
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L
• MDR Report Key: 14043039
• MDR Text Key: 288867068
• Report Number: MW5108805
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTRAVENOUS DRIP; PHENYLEPHRINE
• Patient Outcome(s): Life Threatening; Death; Disability; Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White