MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX TPE

Catalog Number 107144

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

Patient Problems Erythema (1840); Low Blood Pressure/ Hypotension (1914); Pain (1994)

Event Date 04/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A patient was receiving therapeutic plasma exchange (tpe) using a prismaflex tpe 2000 set and a prismaflex control unit for the first time.Shortly after treatment start, when the infusion of fresh frozen plasma was started, the patient presented with erythema of the trunk, bilateral back pains, chest pains and hypotension.The infusion of fresh frozen plasma was stopped.The treatment was then restarted using another fresh frozen plasma bag, applying a lower blood flow.No additional information is available.

• Brand Name: PRISMAFLEX TPE
• Manufacturer (Section D): GAMBRO INDUSTRIES; 7 avenue lionel terray; meyzieu 69883 ; FR 69883
• Manufacturer (Section G): GAMBRO INDUSTRIES; 7 avenue lionel terray; meyzieu ; FR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6547897
• MDR Text Key: 74552601
• Report Number: 8010182-2017-00025
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: 107144
• Device Lot Number: 16K1704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2017
• 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: PRISMAFLEX MACHINE (SN: UNKNOWN)
• Patient Outcome(s): Other