MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX TPE

Model Number 107144

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

Patient Problems Headache (1880); Hot Flashes/Flushes (2153); Tingling (2171)

Event Date 11/29/2015

Event Type  Injury  

Event Description

A patient in the uk was undergoing his first therapeutic plasma exchange (tpe) on a prismaflex machine and a prismaflex tpe set.The patient developed a headache, tingling toes and flushing all over.Treatment was discontinued without returning the blood in the extracorporeal circuit resulting in a blood loss of approximately 100 ml.The patient was administered 100 mg of iv hydrocortisone, and 10 mg of piriton.Following this event the patient successfully received in total 5 tpes where he allegedly was provided hydrocortisone and piriton prior to treatment start.

• 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: 5332023
• MDR Text Key: 34577164
• Report Number: 8010182-2015-00095
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: 107144
• Device Lot Number: 15I3004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• 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: 23 YR