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

Model Number PLASMAFLO OP

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

This incident occurred in (b)(6) and we are reporting this event since we consider the severity of the event is serious injury as the patient experienced shock and causal relationship between this device and the event could not be denied because the event happened during the treatment.The root cause could not be identified.The adverse event may have been caused by clinical condition of the patient.We are unable to investigate since the actual used medical device was not returned to us and the lot number was unknown.

Event Description

In (b)(6) 2017, the patient was given the treatment with immunoadsorption plasmapheresis with plasma separator (plasmaflo op).At the beginning of the treatment, the systolic blood pressure decreased from 110 mmhg to 90 mmhg and the lower extremities were elevated for the intervention.The treatment was restarted at 15% of the plasma separator flow rate.Since the systolic blood pressure was able to maintain between 100 to 110mmhg at this flow rate for an hour, the plasma separator flow rate was increased to 18%.After 15 minutes of this increase of the flow rate, the systolic blood pressure was dropped to approximately 80mmhg.When the blood pressure was re-measured, the systolic blood pressure was between 50mmhg to 60mmhg and the heart rate was between 80bpm to 110bpm with atrial fibrillation.The treatment was discontinued and the blood was returned to the patient.The physician was called since the blood pressure did not increase as well as the heart rate was decreased to approximately between 40bpm to 50bpm with bradycardia even though normal saline 100ml via intravenous was administered.After an additional normal saline 200ml and 2ml of ephedrine 1 ample(1ml) diluted with normal saline 10ml were administered, the systolic blood pressure and the heart rate were returned to 120mmhg and 80bpm.The patient went back to the room of the admitted unit after the observation which the systolic blood pressure was recovered to 110mmhg.

• 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: 7147178
• MDR Text Key: 95799879
• Report Number: 8010002-2017-00050
• 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: Health Professional
• Type of Report: Initial
• Report Date: 12/07/2017

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 Operator: Health Professional
• Device Model Number: PLASMAFLO OP
• Device Catalogue Number: OP-05W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/27/2017
• 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: IMMUSORBA TR-350
• Patient Outcome(s): Life Threatening