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 04/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A patient was treated with therapeutic plasma exchange (tpe) for the tenth time.The therapy was started using a prismaflex tpe 2000 set (which had been primed using 3 liters of physiological serum) and a prismaflex control unit.Approximately 15 minutes after having started the extracorporeal blood circulation and prior to starting the plasma exchange, the patient presented with back pain.The patient received 1 g paracetamol as well as polaramine (dexchlorpheniramine) after which the treatment was terminated with blood return since the pain was not decreasing.The pain only disappeared after approximately an hour, after having received additional oral administration of tramadol.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: 6702477
• MDR Text Key: 79656135
• Report Number: 8010182-2017-00046
• 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: 07/28/2017

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: 06/19/2017
• Initial Date FDA Received: 07/11/2017
• Supplement Dates Manufacturer Received: 07/11/2017
• Supplement Dates FDA Received: 07/29/2017
• 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
• Treatment: PRISMAFLEX MACHINE (SN: UNKNOWN)
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 56