MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX TPE

Model Number 115315

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

Unknown.

Event Description

A patient in (b)(6) was treated with therapeutic plasma exchange (tpe) using a prismaflex tpe2000 set and a prismaflex machine.The prismaflex set was primed using 3300 ml saline prior to start of treatment.Approximately 30 minutes after the start of treatment the prismaflex machine generated a blood leak alarm.Reportedly, air was noticed in the venous chamber and an external blood leakage was observed at the arterial pod.The treatment was discontinued without returning the extracorporeal blood to the patient resulting in an estimated blood loss of 175 ml.The patient's clinical condition post event remained unchanged.

• Brand Name: PRISMAFLEX TPE
• Manufacturer (Section D): GAMBRO INDUSTRIES; 7 avenue lionel terray; meyzieu 69883 ; FR 69883
• Manufacturer Contact: thierry palkovics ; 7 avenue lionel terray; meyzieu ; FR ; 472452525
• MDR Report Key: 5353477
• MDR Text Key: 35773156
• Report Number: 8010182-2016-00005
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: 115315
• Device Lot Number: 15F2609A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2015
• 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): Other
• Patient Age: 16 YR
• Patient Weight: 60