MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 115307

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the inner tube wall of a prismaflex m150 set ckt had a ¿nonuniform thickness.¿ the reporter indicated that around 10 minutes into the treatment, the blood pump was found to ¿not run quite smoothly.¿ further inspection of the set after treatment revealed the set issue.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: the actual device was not available; however, photographs of the sample were provided for evaluation.On the pictures provided, the blood pump segment had an unusual appearance.However, these pictures are not clear enough to determine the exact nature of the defect.The cause of the condition was not determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX M150
• 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: 7160251
• MDR Text Key: 96708262
• Report Number: 8010182-2017-00188
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080519
• 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,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115307
• Device Lot Number: 16I2307V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/23/2016
• 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