MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX TPE

Model Number N/A

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pain (1994)

Event Date 03/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A patient was treated with therapeutic plasma exchange (tpe) for the first time.The therapy was started using a prismaflex tpe 2000 set (which had been primed using 3 liters of saline) and a prismaflex control unit, as well as 4% albumin as replacement solution.Anticoagulation was achieved using 200 units of heparin as a loading dose then infusion of 500 units/hour.Blood flow was set at 300ml/min, and the replacement of 3.6l of plasma was planned.Thirty minutes into treatment, during the infusion of the first bag of 4% albumin, the patient presented with hypotension, nausea, vomiting, chills and lower back pains.Due to this event, the plasma removal and the infusion of 4% albumin was stopped (blood was still circulating in the prismaflex tpe 2000 set), and the patient received 100 ml of saline solution and 50 mg of tramadol.Around 10 minutes after the apparition of the symptoms, the patient started feeling better.An electrocardiogram (ecg) was performed which showed a right branch block.Tpe treatment was then discontinued, and the patient was addressed to a cardiologist (outcome not reported).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: 6702480
• MDR Text Key: 79655408
• Report Number: 8010182-2017-00047
• 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: 07/11/2017

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: 10/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 107144
• Device Lot Number: 16J0604
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2017
• Initial Date FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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 MACHINE (SN: UNKNOWN)
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 56