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

Additional 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: 5353553
• MDR Text Key: 35694376
• Report Number: 8010182-2016-00002
• 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