MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL XTRA WASH SET 225ML; APPARATUS, AUTOTRANSFUSION - XTRA AUTOTRANSFUSION SYSTEM

Model Number BOWL SET X/225

Device Problem Chemical Problem (2893)

Patient Problems Bradycardia (1751); Hemolysis (1886)

Event Date 01/28/2022

Event Type  Injury  

Manufacturer Narrative

Livanova usa inc manufactures the xtra wash set 225ml.The incident occurred in (b)(6).During follow up with the customer, livanova has been informed that, blood treated by the cell saver during the second bowl was dark.According to customer, this was associated with massive hyperkalemia during the transfusion.Hemoglobin in the collected blood was 7.9 g/dl.According to customer, there was no anomaly reported apart from the orange light provided by the equipment relevant to waste line of the cycles 1, 2 and 5 and red color for cycles 3, 4 and 6.The auto mode was planned.However, processing volume was lower.Possible manual trigger to be investigated by livanova.During 6th cycle, possible reconcentration has to be investigated.According to customer, the results were unexpected in cycle 3 and 4 which might suggest major hemolysis of the blood before and after treatment.Customer has asked if there are barriers to put in place to detect a malfunction.The customer has provided to livanova the extended report of the xtra equipment that was used during the event.The extended report is generated automatically by the equipment and provides the exact sequence of events during the use of the disposable device.In the extended report, it is visible that the customer is using a self-made-customized program in which the wash volume is 500ml and wash flow is 350 ml/min.In the xtra user manual (chapter 5: processing - protocol parameters page 5-30), the recommended parameters for ats protocols for bowl 225ml are wash volume 1000ml and wash flow 500ml/min.The smaller wash volume and wash flow, with respect to recommended values, have likely impaired the washing efficiency.It shall be noticed that the xtra user manual also explains the wash phase screen will display a waste line color indicator dot which changes color from red to yellow to green with the color of the waste line (red indicating an opaque color; green indicating a transparent color).In addition, in the instructions for use of the disposable bowl sets it is recommended to wash the collected blood in the case of hemolysis and the decision to reinfuse the collected blood is under the evaluation of the relevant physician (contraindications-¿, the use of blood from this device for reinfusion may be contraindicated, e.G., in the presence of certain potentially harmful substances (refer to cell separator manual for more detail).The responsibility for the use of the device in all cases belongs solely to the physician in charge.; reinfusing salvaged blood - it is recommended that intraoperative and postoperative autologous blood be processed.The washing operation is necessary whenever the recovery is carried out in the presence of heavy hemolysis caused by surgery, or in cases of high coagulopathy or hepatic or renal failure.The decision to re-infuse the blood components obtained by this concentration-washing procedure is the responsibility of the attending physician.Limit the reinfusion of unprocessed blood to the surgical situations of real necessity.The decision to reinfuse unprocessed blood is on the sole responsibility of the physician in charge.If reinfusing unprocessed blood, the use of a microaggregate filter on the patient reinfusion line is mandatory.) livanova has organized a meeting with the customer to discuss the event and agreed the wash volumes might have contributed to the issue.The customer is evaluating a new meeting to discuss over the general use of the device.The functionality of the xtra equipment has been verified and found fully functional.Disposable device unit will be investigated at livanova (b)(4).If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) has received a report that, on (b)(6) 2022, during an emergency procedure, sudden hypotension occurred.Medical team administer blood collected from the cell saver to the patient.According to information, during the administration, blood was dark color and administration was interrupted.At this time, patient showed bradycardia and medical team elected to administer atropine to the patient and to perform blood gases analysis.Blood gases analysis showed high serum potassium (6.7 mmol/l) that medical team elected to treat by injection of calcium chloride and insulin/glucose, control at 4 mmol/l.The medical team sent to analysis the dark blood and high potassium (22.5 mmol/l) and sodium (14 mmol/l) were found.According to customer, hyperkalemia on potential hemolysis of the content of cell saver has occurred.The patient has been transferred to resuscitation/intensive care for monitoring and is now stable.Disposable device has been saved by the customer.

Manufacturer Narrative

As reported during initial investigation, xtra equipment used during the procedure was checked by livanova field service engineer and found to be functional, thus excluding any equipment failure.The analysis of the extended report provided by the customer relevant to the xtra equipment showed that the customer did not use a pre-set factory protocol but a user-defined custom protocol.The user-defined customized set could have induced poor washing efficiency review of the manufacturing records of the xtra disposable device confirmed the device was released conforming to product specifications.No further similar complaints have been recorded for noticed product lot on a total of manufactured units.Livanova is not aware of any other similar event related to xtra disposable devices thus confirming this is any isolated event.Complained xtra wash set was returned to mirandola for investigation.Visual inspection of the device was performed and no inhomogeneity or anomaly was found thus excluding disposable malfunctions.In conclusion, no malfunctions or deviations of the product were identified, consequently the main cause of the event was determined in customized parameters of the machine set in correlation with the specific characteristics of the patient's blood.The risk is in the acceptable region.No specific action is deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: XTRA WASH SET 225ML
• Type of Device: APPARATUS, AUTOTRANSFUSION - XTRA AUTOTRANSFUSION SYSTEM
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 13665461
• MDR Text Key: 286563616
• Report Number: 9680841-2022-00013
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 08033178110044
• UDI-Public: (01)08033178110044(17)241005(10)2110070071(11)211007(240)04253
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: D107186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BOWL SET X/225
• Device Catalogue Number: 04253
• Device Lot Number: 2110070071
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR