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

Model Number OP-08W

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

Patient Problem Anaphylactic Shock (1703)

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

The complaint prodcut was not analyzed since it was discarded at the hospital.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.Since anaphylactic shock occurred during treatment using the device, it was determined that a causal relationship "cannot be denied." the physician determined this event as "non-serious injury", but we determined this event as "serious injury".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 when artificial liver treatment was performed on a patient in china.Plasmaflo op is identical model to op-05w(a) marketed in us.After starting treatment, the patient developed anaphylactic shock symptoms.Artificial liver treatment was stopped, and fluid replacement, vasopressors, and antiallergic drugs were administered to the patient, and the heart rate and blood pressure gradually returned to normal.

• 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, 87003 96; JA 8700396
• Manufacturer Contact: naomi kagam ; 1-1-2 yurakucho; chiyoda-ku; tokyo, 100-0-006 ; JA 100-0006
• MDR Report Key: 18957522
• MDR Text Key: 338305317
• Report Number: 8010002-2023-00050
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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: 8N3V48
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2023
• 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: 66 YR
• Patient Sex: Male