MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX TPE

Model Number 107144

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Pain (1994); First Use Syndrome (2239)

Event Date 01/25/2016

Event Type  Injury  

Manufacturer Narrative

Unknown.

Event Description

A patient in (b)(6) with encephalomyelitis was undergoing her 31st therapeutic plasma exchange (tpe) treatment.Approximately 2 minutes after the treatment started, the patient developed sudden back pain and nausea.The patient was treated with paracetamol, tramadol and metoclopramide; the treatment was discontinued without returning the blood in the extracorporeal circuit and restarted an hour later.

• Brand Name: PRISMAFLEX TPE
• Manufacturer (Section D): GAMBRO INDUSTRIES; 7 avenue lionel terray; meyzieu 69883 ; FR 69883
• Manufacturer Contact: thierry palkovics ; 7 avenue lionel terray; meyzieu ; FR ; 472452525
• MDR Report Key: 5590781
• MDR Text Key: 43125696
• Report Number: 8010182-2016-00027
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P830063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/20/2016

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: 11/01/2018
• Device Model Number: 107144
• Device Lot Number: 15K3003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2015
• 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: PRISMAFLEX (SN UNKNOWN).
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR