MAUDE Adverse Event Report: KANEKA CORP. LIPOSORBER LA-15 SYSTEM; APHERESIS SYSTEM

Model Number LA-15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Tachycardia (2095)

Event Date 01/25/2019

Event Type  Injury  

Event Description

A (b)(6) y.O boy with recurrent fsgs post-transplant.Has been receiving plasmapheresis up until today.Gfr well below 60 but a moot point in post-transplant; serum creatinine 2.9; serum protein 4.6; albumin 3.5; h&h 9.2, 28.6; 305 platelets.He was on ace-i (enalapril) and off for 72 hours according to his mother.He had a double lumen ij patent with good flows.Plasma volume tb treated 4,200 ml (90kg x 60ml).1.8 u heparin for bolus and 1.8 u heparin during treatment (25 u per kg).Two alarms early on for venous pressure which were quickly remedied with a flush.His mother states that one of the ports was not working well and the nurses doing the plasmapheresis only used one of the ports.Started at 60ml bfr and 20% pfr.Treatment started at 09:48 vss 125/76-84-16 skin warm, and dry color normal at 10:04, 16" into treatment, patient complained of chest pain and started thrashing in the bed; color pale lips cyanotic even though pulse ox 100%.The patient was lowered the head of the bed got o2 non rebreather mask; stopped the pumps had rn give 100 cc bolus normal saline (ns); code called and nurses gave solu medrol 125 and dr.Wanted 500 cc bolus ns given.Vs were 154/84-129-24.Patient within 5 minutes felt better.10:28 bp 128/78-72.Patient transferred to the er.Patient stable after 30 to 40".It was very first experience on him with liposorber switched from plasmaexchange (the last pex was (b)(6) 2020).Mfr# 3002808904-2019-00005.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Type of Device: APHERESIS SYSTEM
• Manufacturer (Section D): KANEKA CORP.; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 530-8 288,; JA 530-8288,
• MDR Report Key: 11036533
• MDR Text Key: 222628071
• Report Number: 2435151-2020-00002
• Device Sequence Number: 1
• Product Code: PBN
• UDI-Device Identifier: 14993478010110
• UDI-Public: 14993478010110
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2019,12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LA-15
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 15 YR