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

Model Number OP-05W

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pneumonia (2011)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

This incident of eosinophilic pneumonia occurred in (b)(6), and we are reporting this event to fda according to the requirement.Plasmaflo op-05w is similar model of plasmaflo op-05w(a) marketed in us.The actual used product was not returned to us for investigation and could not be analyzed, and the lot number was unknown.We have not received any event of eosinophilic pneumonia other than this case since we started selling plasmaflo op globally.Patient's physician considers that this case is serious event and that causal relationship between plasmaflo op and this event is possible, and the doctor whose hospital this patient was transferred to commented that this case is possibly related to iapp.We also consider the severity of eosinophilic pneumonia is serious injury as patient has hospitalized for the treatment of pneumonia and was given the treatment of mechanical ventilator, and the causal relationship between this device and the event could not be denied because the event happened just after iapp treatment.The caution for this event is not described in instruction for use, however this case is the first event happened on plasmaflo op, we will continue to vigilance trend in occurring this kind of event(eosinophilic pneumonia) with plasmaflo op.

Event Description

A (b)(6) woman started the treatment with immunoadsorption plasmapheresis(iapp) of plasmaflo op-o5w and immusorba tr-350 for myasthenia gravis on (b)(6), and was given the treatment with iapp on (b)(6).On (b)(6) 2018, she was given the seventh treatment with iapp of plasmaflo op-o5w and immusorba tr-350 for myasthenia gravis.Just after catheter withdrawal, this patient experienced respiratory discomfort.Conclusion of air in her blood was suspected to have occurred, and chest x-ray was taken, which showed opacity like the diffuse pneumonia in her left lung.Soon after she returned to the hospital ward, her symptom worsened and oxygen was given via oxygen mask, but still she could not maintain her breathing, and she was given the treatment with ventilator.Acute respiratory distress syndrome(ards) was suspected, and she was given the treatment of antibiotic meropenem and elaspol, but she could not wean from mechanical ventilator.On (b)(6) 2018, this patient was admitted to another hospital, and was given the treatment with antifungal agent for allergic bronchopulmonary mycoses.In the end of march, she was given the conservative medical management.She has recovered and was discharged from the hospital.

• Brand Name: PLASMAFLO OP
• Type of Device: PLASMA SEPARATOR
• Manufacturer (Section D): ASAHI KASEI MEDICAL CO., LTD.; 1-105, kanda jinbocho; chiyoda-ku; tokyo 101-8 101; JA 101-8101
• Manufacturer (Section G): ASAHI KASEI MEDICAL MT CORP.; oita works; 2111-2 oaza sato; oita-shi, oita 870-0 396; JA 870-0396
• Manufacturer Contact: akitake yamashita ; 1-105, kanda jinbocho; chiyoda-ku; tokyo 101-8-101 ; JA 101-8101 ; 32963735
• MDR Report Key: 7497644
• MDR Text Key: 107694678
• Report Number: 8010002-2018-00040
• 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: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OP-05W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: BLOOD PURIFICATION MACHINE ACH-SIGMA; CALFINA TAB.0.5; CLARITHROMYCIN TABLET; HEPARIN; IMMUSORBA TR-350; LANSOPRAZOLE ORALLY-DISINTEGRATING TABLET; PLASMAPHERESIS BLOOD TUBING SET PA-SG; PREDNISOLONE 5MG TABLET; THEOPHYLLINE EXTENDED-RELEASE TABLET 100MG
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR
• Patient Weight: 30