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 11/01/2017

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 with cardiac arrest and the causal relationship between this device and the event could not be denied because the event happened during the treatment.The actual used product was not returned to us for investigation and could not be analyzed, however the lot number was reported and we are reviewing the manufacturing and quality control records.We will make additional report to fda as soon as we get the result.Analysis will be proceeded base on lot number.

Event Description

During her first plasma exchange (pe), the patient went into shock with cardiac arrest 30 minutes after the connection.She was treated for a guillain barre syndrom.No other plasma exchange is planned as the patient is now treated by intravenous immunoglobulin(ivig).The patient did not suffer from aftereffects and got back home after a few hours under surveillance in the hospital.

Manufacturer Narrative

The used device could not be analyzed because it was discarded by the user facility, however we investigated manufacturing and quality control records based on the lot number.According to the investigation, no potential for malfunction was found.We could not identify the root cause.

• 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: 7136823
• MDR Text Key: 95451469
• Report Number: 8010002-2017-00040
• 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
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

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 Expiration Date: 01/31/2020
• Device Model Number: PLASMAFLO OP
• Device Catalogue Number: OP-08W
• Device Lot Number: FG1W2B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 11/30/2017
• Supplement Dates FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• 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): Other
• Patient Age: 61 YR
• Patient Weight: 83