MAUDE Adverse Event Report: KANEKA CORPORETION LIPOSORBER LA-15 SYSTEM; LIPOPROTEIN, LOW DENSITY, REMOVAL

Model Number	LA-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Anaphylactoid / Anaphylaxis (2218)
Date of Event	10/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No lot number was reported for the device.Therefore, reviewing the device history record (dhr) was not possible.Our views; there have been no reported problems when using the device.Adverse events are determined to be due to the patient's condition and method of use.However, we are submitting an mdr (30 days) because health damage to patients has occurred and a causal relationship between the health damage and the product cannot be completely denied.Anaphylactoid reaction: the ifu of la-15 states that the device should be used carefully in patients in pregnancy because until now little clinical data are available.Also, as known side effects of liposorber la-15 anaphylactoid reactions are named in this ifu.Sudden coagulation in the disposable: we identified the potential that the pauses of the blood pump caused by the intervention and alarms may have contributed to the coagulation in the extracorporeal system as well as maybe the low heparin flow rate 0.1ml/h.
Event or Problem Description
Patient at the 22 week of gestation.Initial bolus of approximately 3500 iu of sodium heparin (subsequent continuous infusion at 0,1 ml / hour).Start of treatment with blood flow 50 ml / min - plasma flow 15 ml / min.At approximately 50 ml of treated plasma onset of skin flushing, tachycardia and headache.This required zeroing the plasma pump and administering iv saline with regression of symptoms in about 5 minutes.The treatment then continued with extraction at 5-7% and blood flow of 30-40 ml / min based on the clinical symptoms presented by the patient.At 700 ml of treated plasma sudden coagulation in the disposable.Premature termination of the treatment with blood / plasma loss.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Common Device Name: LIPOPROTEIN, LOW DENSITY, REMOVAL
• Manufacturer (Section D): KANEKA CORPORETION; nakanoshima; kita-ku; osaka, 530-8 288; JA 530-8288
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1 torikai-nishi; settu-city, osaka 56600 72; JA 5660072
• Manufacturer Contact: joji sengoku ; akasaka 1-12-32; minato-ku; tokyo 10711-52 ; JA 1071152
• MDR Report Key: 15822448
• Report Number: 3002808904-2022-00015
• Device Sequence Number: 17643548
• Product Code: MMY
• UDI-Device Identifier: 14993478010110
• UDI-Public: 14993478010110
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: LA-15
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White