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

Model Number OP-08W

Device Problem Biocompatibility (2886)

Patient Problem Anaphylactic Shock (1703)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

The product of this event was not returned to the manufacturer and could not be analyzed; however, we investigated manufacturing and quality control records based on the lot number.According to the investigation, no potential for malfunction was found and no similar event has been reported with this lot number globally so far.The physician determined this event as "non-serious injury", but we determined to report this incident since we consider anaphylactic shock as "serious injury" and the causal relationship between the anaphylactic shock and the use of the medical device cannot be denied.Anaphylactic shock is described as anaphylactoid reactions in ifu." e.Precautions 13.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.The other potential reactions due to available substitute fluid such as fresh frozen plasma, plasma protein fraction are anaphylactoid reactions, hypocalcemia and infection." we will continue to monitor the occurrence of similar events carefully.

Event Description

This incident occurred in japan.Plasmaflo op-d series is identical model to op-05w(a) marketed in us.Immunoadsorption therapy (iapp) was performed with plasmaflo op-08d and a selective plasma component adsorption column (immusorba tr-350) for a patient with guillain-barré syndrome.When plasma throughput reached 1,600ml at the time of the first therapy, the patient became unconscious and shock.Cardiac massage was performed.Flushing of the face was observed.Blood was returned to the patient immediately, and the patient recovered with noradrenaline and fluid replacement.The treatment was completed.Blood pressure at baseline was 106/90 mmhg, and blood pressure during shock was 92/54 mmhg.In addition, the second therapy was carried out with limited throughput, and 1,200ml treatment was able to be performed without any issues.

• 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: 16369320
• MDR Text Key: 309479537
• Report Number: 8010002-2023-00010
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/19/2023

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 Operator: Health Professional
• Device Model Number: OP-08W
• Device Lot Number: 3L6Q72
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMMUSORBA TR-350
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Male