MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX M100 SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 106697

Device Problems Crack (1135); Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A patient in brazil was undergoing continuous renal replacement therapy (crrt) with a prismaflex m100 set.It was reported that the effluent line was leaking shortly after initiation of therapy.The defect was reportedly inside the line, where it connects to the bag.

• Brand Name: PRISMAFLEX M100 SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• 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 ; 2249487578
• MDR Report Key: 6249781
• MDR Text Key: 64907411
• Report Number: 8010182-2017-00001
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K041005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2018
• Device Model Number: 106697
• Device Lot Number: 16D2105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2202-2014
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX (SN:UNKNOWN)
• Patient Outcome(s): Other