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

Model Number OP-05D

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

Patient Problem Urticaria (2278)

Event Date 03/29/2024

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 not similar event has been reported with this lot number globally so far.The physician determined, this event as "non-serious injury" and the cause of the urticaria may have been due to use of fresh frozen plasma, but causal relationship between urticaria and the use of the medical device cannot be denied.We consider this event as "serious injury" since it was a systemic urticaria and medications are being administered via iv as a treatment.Although fresh frozen plasma may be the cause of the urticaria, the causal relationship between the urticaria and the use of the medical device cannot be denied because it occurred during the use of the medical device.Urticaria is described as one of the adverse events in "e.Precautions" of ifu.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.Patient with multiple sclerosis received plasmaapheresis therapy using op-05d.Fresh frozen plasma was used for replacement fluid.After completion of plasmapheresis therapy on (b)(6) 2024, itchy urticaria was developed.The areas where the urticaria occurred were the face, neck, both hands, part of the upper arm, and the left groin.After administering 1 vial of d-chlorpheniramine maleate and 125mg of methylprednisolone sodium succinate via iv, the patient's condition gradually improved and recovered within the same day.

• 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: 19171046
• MDR Text Key: 340899590
• Report Number: 8010002-2023-00060
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2024

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 Model Number: OP-05D
• Device Lot Number: QN838J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 68 KG