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

Model Number OP-05W(A)

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2019

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 u.S.The product in complaint was not returned to the manufacturer and could not be analyzed.The lot number in complaint was not reported and we could not review the manufacturing and quality control records.According to the physician comment about the relationship between this product and the patient's death, this treatment of op and prasorba brs might have caused the patient's early death.We judged that this case as serious adverse event because the outcome is death.The causal relationship between these events and op are not denied because the patient's clinical laboratory data were aggravated after the treatment, and that this patient died 6 hours after the end of the treatment.This case information was derived from the inquiry from the customer, so follow-up information about the cause of the death could not be obtained.The caution as to the patients with low platelet count is written in the ifu as follows.In the "e.Precautions", as "15.The plasmaflo¿ op-05w(a) is not recommended for use with the following patients, except where specifically approved by and used in accordance with the directions of the responsible physician.Patients with low platelet count" however, "platelet count decreased, prothrombin time prolonged" is not written in the ifu, but this case is their first adverse events 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: the level of this patient's blood pressure was low from the morning, and the patient's aspiration was managed with the ventilator before bilirubin adsorption treatment.This patient was treated with bilirubin adsorption treatment of plasmaflo op-05w used as plasma separator and similar product of op-05w(a) sold in us, and plasorba brs, absorptive removal column of bilirubin and bile acid, to absorb bilirubin.Patient's platelet count decreased from 116,000/ul to 102,000/ul.Prothrombin time increased from 15.6 seconds to 22.5 seconds.On (b)(6) 2019: this patient was treated with bilirubin adsorption therapy.Platelet count decreased from 102,000 /ul to 82,000 /ul.Prothrombin time increased from 19.1 seconds to 29 seconds.13:25, the treatment with bilirubin adsorption therapy was stopped.No bleeding around the catheter at the vascular access of the groin.19:18, this 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: 8525799
• MDR Text Key: 142320346
• Report Number: 8010002-2019-00040
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OP-05W(A)
• 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: 03/22/2019
• 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
• Treatment: PLASORBA BRS
• Patient Outcome(s): Death