MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX TPE

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A patient was treated with therapeutic plasma exchange (tpe), using a prismaflex tpe 2000 set and a prismaflex control unit for the third time.This was the first time they received this treatment in this hospital.During this treatment, the patient reportedly presented with severe back pains, that they rated 10 on a 10 levels pain scale.The infusion of replacement solution was stopped and the patient was administered antihistamine (polaramine) and corticoids.The infusion of replacement solution was restarted one hour later, and the treatment was successfully completed with the same prismaflex tpe 2000 set, without further pain reported by the patient.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: 6569100
• MDR Text Key: 75269363
• Report Number: 8010182-2017-00031
• 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,Followup
• Report Date: 06/22/2017

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: 01/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 107144
• Device Lot Number: 17A1806
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 60