MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX TPE

Model Number 107144

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

Patient Problem Pain (1994)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A patient in (b)(6) was undergoing therapeutic plasma exchange (tpe) with a prismaflex tpe 2000 set.Prior to starting treatment , the prismaflex tpe2000 set was primed with isotrope saline solution and heparin was used as anticoagulation.The patient's blood pressure was 200/94 and pulse 65 bpm at the start of treatment.During treatment, after the replacement of 220 ml plasma with albumin 4 %, the patient experienced intense low back pain.Reportedly, the patient felt pain from the ears to the feet, and it felt like an ¿electrical shock¿ making it impossible for her to stay in lying position.The replacement flow rate was stopped and the patient was given 1 g paracetamol, 5 mg oxynormoro and 500 mg solumedrol.The treatment was discontinued without returning the blood n the circuit to the patient.Following this event the next six treatments were immunoadsorption sessions.

• 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 ; 2249487578
• MDR Report Key: 6201672
• MDR Text Key: 63187402
• Report Number: 8010182-2016-00095
• 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: 12/22/2016

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: 05/01/2019
• Device Model Number: 107144
• Device Lot Number: 16E1207A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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: (B)(4)).
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR