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

Model Number OP-05W

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pulmonary Edema (2020); No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2019

Event Type  Death  

Manufacturer Narrative

This incident occurred in (b)(6) and is reported to fda according to the requirement.Op-05w is identical model to op-05w(a) marketed in us.The product of this event was not returned to the manufacturer and could not be analyzed.The lot number of the product was not reported and we could not review the manufacturing and quality control records.According to the physician's comment, her treatments of dfpp from the first one to the fourth one were performed without any problem.After several hours from the end of the fifth treatment of dfpp, she developed acute pulmonary oedema, as the result of elevation of her blood vessel permeability caused by the allergic reaction etc.The cause of this event was known, either by the displacement liquid or by dfpp.The physician considered that this event was not caused by op because this event occurred several hours after the end of the dfpp treatment, but that the causal relationship between this event and op was not denied as direct cause of this event was not identified.We considered that this event was serious adverse event because the outcome was death.The causal relationship between the event and op was not denied, because the patient experienced the acute pulmonary oedema after her dfpp treatment.The caution as to this event is not written in the package insert of op, but this case is the first adverse event whose causal relationship was not denied for us to receive, we will continue to monitor the occurrence of these kinds of events.

Event Description

This case occurred in the facility of (b)(6).On (b)(6) 2019: this patient was started with the fifth treatment of double filtration plasma exchange(dfpp) of op-05w, which was used as plasma separator and was similar product of op-05w(a) sold in us, and cascadeflo ec-20w, which fractionate plasma into large and small molecular weight components.After three hours from the beginning of the treatment, her treatment finished, and she returned her room.After four hours from the end of the treatment, she was found fallen down in the rest room.After four hours and half from the end of the treatment, her hemoglobin(hb) value increased to 17.8 g/dl.After seven hours from the end of the treatment, the result of the computed tomography scan test showed suspected pneumonedema.After seven hours and forty five minutes from the end of the treatment, her hb value increased to 20.4 g/dl.After eight hours from the end of the treatment, her aspiration was supported with the noninvasive positive pressure ventilation(nppv), but did not improve, so she was given the treatment with cannulation.She was diagnosed as acute respiratory failure, acute heart failure, and acute pulmonary oedema, and was transferred to the intensive-care unit.On (b)(6) 2019: after 13 hours from the end of the treatment, the patient experienced acidosis, and was given the treatment with continuous renal replacement therapy (crrt).After 15 hours from the end of the treatment, the patient has died.

• 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.; oita works; 2111-2 oaza sato; oita-shi, oita 870-0 396; JA 870-0396
• Manufacturer Contact: akitake yamashita ; 1-1-2 yurakucho, chiyoda-ku; tokyo 100-0-006 ; JA 100-0006
• MDR Report Key: 8602378
• MDR Text Key: 144801673
• Report Number: 8010002-2019-00070
• 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: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OP-05W
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2019
• 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
• Patient Outcome(s): Death
• Patient Age: 74 YR