MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX M60 SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number PRISMAFLEX M60 SET

Device Problems Crack (1135); Leak/Splash (1354); Connection Problem (2900)

Patient Problem Blood Loss (2597)

Event Date 01/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A patient in (b)(6) was undergoing continuous renal replacement therapy (crrt) with a prismaflex m60 set.At the connection of the patient, a leak occurred at the level of the connection between the access line and the catheter.The bloods loss is estimated at 20 ml.Reportedly, the inner part of luer lock of the access line was broken.

• Brand Name: PRISMAFLEX M60 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: 6298691
• MDR Text Key: 66458446
• Report Number: 8010182-2017-00008
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• 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: PRISMAFLEX M60 SET
• Device Catalogue Number: 106696
• Device Lot Number: 16D1304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2017
• 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-2201-2014
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX (SN:UNKNOWN)
• Patient Outcome(s): Other