MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX TPE

Model Number 115315

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 11/26/2015

Event Type  malfunction  

Manufacturer Narrative

Unknown.

Event Description

A patient in (b)(6) was treated with therapeutic plasma exchange (tpe) which included a prismaflex tpe2000 set and a prismaflex machine.At the time of treatment start an external blood leak (estimated at 3 ml) was reportedly observed on the tpe2000 set at the connection of the return line.An unknown machine alarm was reportedly generated and treatment was discontinued.

Manufacturer Narrative

The return line from the prismaflex tpe2000 ckt set where the leak reportedly occurred has been returned for investigation.Visual inspection of the returned line confirmed the presence of a hole on the line.However, it is unlikely that this defect occurred during our manufacturing process since it would have been detected during our in-process test.The root cause of the reported event remains unknown.

• 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: 5353550
• MDR Text Key: 35760257
• Report Number: 8010182-2016-00003
• 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,Followup
• Report Date: 02/10/2016

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: 05/31/2018
• Device Model Number: 115315
• Device Lot Number: 15E2004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2015
• 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