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

Model Number LA-15

Device Problem No Apparent Adverse Event (3189)

Patient Problem Unspecified Kidney or Urinary Problem (4503)

Event Date 04/20/2022

Event Type  Injury  

Event Description

The patient's fifth liposorber treatment was completed on (b)(6) 2022.The site reported no device issues or complications during treatment.The patient was hospitalized from (b)(6) 2022 to (b)(6) 2022 due to acute kidney injury and was released when recovered.Patient also was reported to have shortness of breath and chest pain which were assessed as not related to liposorber treatment by the physician.The acute kidney injury relationship to treatment with liposorber was assessed as unknown.However, the physician has continuing the patient on liposorber treatments.

Manufacturer Narrative

Possible causes of the problem: no equipment or other problems occurred during treatment.From the patient's history, we infer the possibility that this was not an adverse reaction related to the device in question, but rather an aggravation of a pre-existing condition; however, from 'the information obtained, a causal relationship could not reasonably be ruled out.Conclusion: as a result of the investigation, the cause of the failure could not be identified.The number and frequency of past occurrences similar to the said defects are as follows during the past three years (may 2019 to end of april 2022), there have been two cases (including this case) reported concerning health hazards similar to the case in question.Number of shipments of the product in question the total number of shipments during the above period was 67,603 boxes (domestic and export).Frequency of occurrence: 0.003% (2 cases/67,603 boxes).Mfr report #: 3002808904-2022-00011.

Event Description

See initial report - no changes.

Manufacturer Narrative

Investigation: no similar complaint has been reported by other facilities or customers until now.Conclusion: no abnormality was found in manufacturing and quality control records.In this case, we could not identify the cause of the adverse events.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Type of Device: APHERESIS SYSTEM
• Manufacturer (Section D): KANEKA CORPORATION; 5-1-1, torikai-nishi,; osaka city, osaka 530-8 288; JA 530-8288
• MDR Report Key: 15312087
• MDR Text Key: 298802140
• Report Number: 2435151-2022-00001
• Device Sequence Number: 1
• Product Code: PBN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2022,09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2022
• Distributor Facility Aware Date: 04/28/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 91 KG