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

Catalog Number ASKU

Device Problem No Audible Alarm (1019)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

The event was reported to have occurred "in the last few months. " 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.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - LUND MONITORS; magistratsvagen 16; lund skane lan SE-22 643; SW SE-22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 10649858
• MDR Text Key: 210434085
• Report Number: 9616026-2020-00029
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2020,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2020
• Distributor Facility Aware Date: 09/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2020
• Date Manufacturer Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 10/08/2020 Patient Sequence Number: 1

Treatment

PRISMAFLEX SET