MAUDE Adverse Event Report: ASAHI KASEI MEDICAL CO., LTD. PLASMAFLO OP; PLASMA SEPARATOR

Model Number OP-08W

Device Problem No Apparent Adverse Event (3189)

Patient Problem Hemolysis (1886)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

We conducted a leak test on the hollow fiber of the actual product, but no leakage was found.We also reviewed the manufacturing and quality control records of the lot number and no abnormality was found.Furthermore, a log analysis of the blood purification device was performed, but no alarm was generated to notify the hollow fiber leak during cleaning before the start of treatment, and no abnormality in tmp (transmembrane pressure) was observed after the start of treatment.Also, by the time it was stopped, neither a blood leak alarm nor an alarm indicating abnormal pressure was issued.From these findings, it was assumed that hemolysis was occured rather than blood leakage due to the breakage of the hollow fiber.Regarding seriousness, there was no information to judge this incident is serious based on the clinical data.However, we decided to report this incident since the physician judged as "serious" even though there was no health consequences or impact to the patient.Hemolysis is described in the package insert of plasmaflo op (i.Preface, e.Precautions): hemolysis is an adverse reaction that can occur if the tmp increases above 100mmhg (13.3kpa).Monitor the patient constantly during treatment with the plasmaflo op-05w(a).In the event of any of the following during treatment, immediately ensure the safety of the patient and take appropriate measures in accordance with the directions of the responsible physician.Presence of hemoglobin in separated plasma, due to hemolysis.We will carefully continue to monitor and to be vigilant for the trend of occurrence of this kind of events.

Event Description

This case occured in (b)(6).At 17:40, the 4th double filtration plasmaapheresis(dfpp) treatment was started using plasmaflo op-08w which is similar product of plasmaflo op-05w(a) marketed in us.Approximately 10 minutes later, the nurse visually observed that the outside of the hollow fiber membrane of this product was turned pale pink.The treatment was stopped and the liquid in the outside of the hollow fiber of this product was collected, but no red blood cells were found on examination.In addition, as a result of the blood potassium test of the patient, hemolysis was not confirmed.There were no health concerns with the patient.

• Brand Name: PLASMAFLO OP
• Type of Device: PLASMA SEPARATOR
• Manufacturer (Section D): ASAHI KASEI MEDICAL CO., LTD.; 1-1-2 yurakucho; chiyoda-ku; tokyo, 100-0 006; JA 100-0006
• Manufacturer (Section G): ASAHI KASEI MEDICAL MT CORP.; 2111-2 oaza sato; oita-shi, oita 870-0 396; JA 870-0396
• Manufacturer Contact: naomi kagami ; 1-1-2 yurakucho, chiyoda-ku; tokyo, 100-0-006 ; JA 100-0006
• MDR Report Key: 11152256
• MDR Text Key: 231799061
• Report Number: 8010002-2021-00010
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P820033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2023
• Device Model Number: OP-08W
• Device Catalogue Number: N/A
• Device Lot Number: ZK1T25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2020
• 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): Other
• Patient Age: 27 YR