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 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Facility name: (b)(6)hospital (b)(6).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The actual device was not available; however, a photograph of the sample was provided for evaluation.The visual inspection of the provided picture showed that the pbp and effluent lines were incorrectly assembled on the support plate.The reported condition was verified.The cause of the condition was determined to be a manufacturing issue.The involved operator was retrained and awareness training has been provided to all operators.The batch involved in this report was manufactured prior to these actions.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during patient treatment with a prismaflex m100 set, the effluent line was found to be crossed with pbp line and a clamped line alarm occurred which was proceeded by an effluent fluid weight alarm.There was no patient injury or medical intervention associated with this event.

• Brand Name: PRISMAFLEX M100 SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu cedex rhone
• 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: 7689420
• MDR Text Key: 114021247
• Report Number: 8010182-2018-00084
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414118358
• UDI-Public: (01)07332414118358
• 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: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Catalogue Number: 115306
• Device Lot Number: 17L1301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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
• Treatment: PRISMAFLEX CONTROL UNIT