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

Model Number OP-08W

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

The complaint prodcut has not been analyzed yet since it has just arrived in japan.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 hypersensitivity occurred during treatment using the device, it was determined that a causal relationship "cannot be denied." the physician determined this event as "serious injury", and we also determined this event as "serious injury" since the patient was hospitalized.The cause of hypersensitivity might be an allergy to the membrane material of this product, but it cannot be determined.As for an allergic reaction, anaphylactoid reaction is described 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 are going to prepare a follow-up report as soon as we get the result of the analysis of the complaint product.We will continue to monitor the occurrence of similar events carefully.

Event Description

This incident occurred in france.Plasmaflo op is identical model to op-05w(a) marketed in us.This event occurred when double filtration plasmapheresis (dfpp) was performed on a patient using plasmaflo op.The patient was treated with dfpp for a recurrence of segmental and focal hyalinosis on a renal graft on (b)(6) 2023.20 minutes after starting the treatment, hypersensitivity such as tingling sensation in the lips, paresthesia on the tip of the tongue, nausea, vomiting, diarrhea, abdominal pain, and hypothermia appeared.Double filtration plasma exchange therapy was discontinued.Phloroglucinol, ondansetron, and paracetamol were administered as per ordered.Also, 500 ml of sodium chloride was administered via iv.The patient was hospitalized overnight and recovered.

Manufacturer Narrative

The inspection of the returned complaint product was completed at manufacturing site on december 27, 2023.According to the inspection, there were no abnormalities found and no similar event has been reported with this lot number globally so far.We will continue to monitor the occurrence of similar events carefully.

• 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-sh; ioita, 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: 18333131
• MDR Text Key: 330547692
• Report Number: 8010002-2023-00040
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• 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: 8M6S72
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CASCADEFLO EC-30W.
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 94 KG