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

Catalog Number 955595

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that, during continuous veno-venous hemodiafiltration therapy, one unit of prismaflex m100 set had an external blood leakage due to a disconnection of the replacement pump line.The reported blood was reported as 160ml.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: h6 and h10.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The sample was not returned, however, a picture was returned for evaluation.The visual inspection of the photo provided showed the replacement pump segment was disconnected from the support plate.The cause was a lack of solvent on the extremity of the pump segment indicating manufacturing and operator error.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX M100
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9512183
• MDR Text Key: 195441203
• Report Number: 8010182-2019-00220
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

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: 03/01/2021
• Device Catalogue Number: 955595
• Device Lot Number: 19C1903
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.