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

Catalog Number 115307

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported during priming with a prismaflex m150 set, fluid leakage was observed.It was reported it was due to return tube damage.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction: b4/f8: date of this report in follow-up mdr #1 is being corrected from blank to 07/12/2021.

Manufacturer Narrative

Additional information: d9, h3, h6 and h10.The device was received for evaluation.This sample was visually inspected, and a leak test performed.A leak was observed from the effluent port due to a crack.The reported condition is verified.The cause of the crack was due to a transportation issue.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 CORPORATION; deerfield IL
• MDR Report Key: 11962331
• MDR Text Key: 259588421
• Report Number: 8010182-2021-00188
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2021

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 Catalogue Number: 115307
• Device Lot Number: 20K0904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 07/12/2021; 07/12/2021
• Supplement Dates FDA Received: 07/12/2021; 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1