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 Anaphylactic Shock (1703); Cardiac Arrest (1762); Seizures (2063)

Event Date 04/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A patient initiated therapeutic plasma exchange (tpe), using a prismaflex tpe 2000 set and a prismaflex control unit.Two days later, approximately 30 minutes after starting the fourth tpe treatment session, with the fifth plasma bag infusion, the patient reportedly presented with an ¿anaphylactic shock level 3¿ with severe hypotension, facial edema, cutaneous rash, loss of consciousness, convulsions and cardiac arrest.The treatment was discontinued and the patient was provided both a bolus then with a continuous infusion of adrenaline for 12 hours.Resuscitation was successful and the patient is reported to have recovered without sequelae.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: 6566879
• MDR Text Key: 75146622
• Report Number: 8010182-2017-00029
• 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: 05/15/2017

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: 07/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 107144
• Device Lot Number: 16G1207
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2017
• Initial Date FDA Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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): Life Threatening; Required Intervention
• Patient Age: 27