MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M100 SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 115306

Device Problem Misassembled (1398)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection revealed that the pbp and effluent lines are incorrectly assembled on the support plate.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the condition was determined to be a human error during manufacturing.Awareness training has been provided to all operators to address this issue.This lot was manufactured prior to the training.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during treatment with a prismaflex m100 set, it was noted that the pbp line was crossed with the effluent fluid line.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: PRISMAFLEX M100 SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu
• Manufacturer (Section G): BAXTER HEALTHCARE - MEYZIEU; 7, av lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7588576
• MDR Text Key: 110880154
• Report Number: 8010182-2018-00049
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K041005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: 115306
• Device Lot Number: 17F2006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR