MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF1400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 107142

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported during continuous veno-venous hemodiafiltration treatment with a prismaflex hf1400 set, an external leak at the syringe connection and the top of the filter connection was observed shortly after connecting the patient.This resulted in an unknown amount of blood loss.A blood return was attempted, and the filter set was changed.There was no 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; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX HF1400
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10817286
• MDR Text Key: 216206481
• Report Number: 8010182-2020-00241
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K042938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/10/2020,12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 107142
• Device Lot Number: 19D2204
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2020
• Distributor Facility Aware Date: 10/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX MACHINE; PRISMASOL
• Patient Age: 62 YR
• Patient Weight: 268