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

Catalog Number 109990

Device Problem Disconnection (1171)

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

Event Date 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during patient treatment with a prismaflex m150 set, the top of the filter disconnected and ¿sprayed blood everywhere¿.The cause of the disconnection was not reported.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; however, a drawing of the impacted set was provided.The visual inspection observed that the reported disconnected occurred between the return screwed connector and the blood header.The reported condition was verified.The cause could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction: h1: no.Of events summarized was inadvertently filled out in the previous mdr.This field should have been blank as this report is not eligible for voluntary malfunction summary reporting (vmsr).

• 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: 11597096
• MDR Text Key: 243935096
• Report Number: 8010182-2021-00117
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414090005
• UDI-Public: (01)07332414090005
• Combination Product (y/n): Y
• PMA/PMN Number: K080519
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2021

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 Expiration Date: 05/31/2022
• Device Catalogue Number: 109990
• Device Lot Number: 20F0703
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 05/05/2021; 06/02/2021
• Supplement Dates FDA Received: 05/07/2021; 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.