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

Catalog Number ASKU

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

The event was reported to have occurred "in the last few months." the device was an unknown prismaflex set.Facility name: (b)(6) medical center.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the return line of the prismaflex set became disconnected from the patient's dialysis catheter during continuous renal replacement therapy.It was reported that the patient was recently repositioned with three people for the sole purpose of watching all lines and airways.However, a disconnection was noticed 10 minutes after the repositioning.The prismaflex control unit did not generate an alarm.The return line was clamped and at this time, the machine generated an alarm.The patient was treated with one unit of blood and it was reported that levophed "requirements were increased temporarily".The patient outcome was not reported.No additional information is available.

Manufacturer Narrative

H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10627553
• MDR Text Key: 209846327
• Report Number: 8010182-2020-00198
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/05/2020,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2020
• Distributor Facility Aware Date: 09/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2020
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX MACHINE; PRISMAFLEX MACHINE
• Patient Outcome(s): Required Intervention