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

Catalog Number 107142

Device Problem Disconnection (1171)

Patient Problems Death (1802); Exsanguination (1841)

Event Date 09/22/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the return line of a prismaflex hf1400 set became disconnected (either partially or completely) from the patient's tunnelled dialysis catheter which caused the patient to exsanguinate and subsequently pass away. Reportedly, the prismaflex control unit did not issue an alarm. It was reported that the nurse found the patient in agonal breathing and checked the patient's catheter insertion site but not the actual return line connection point to the catheter. It was also reported that the patient had several blankets and a warming blanket placed over the torso which blocked the visual inspection of the connection points. Resuscitation with fluid and medications was unsuccessful and the patient subsequently passed away. The cause of death was not reported. It was not reported if an autopsy was performed. No additional information is available.

Manufacturer Narrative

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.

Manufacturer Narrative

The customer reported this event to the fda through medwatch 5096970. 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
• Manufacturer (Section G): BAXTER HEALTHCARE - MEYZIEU; 7, av lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 10693092
• MDR Text Key: 211757376
• Report Number: 8010182-2020-00213
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K042938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2020,11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 107142
• Device Lot Number: 20F0305
• 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: 10/15/2020
• Distributor Facility Aware Date: 09/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2020
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 10/16/2020 Patient Sequence Number: 1

Treatment

PRISMAFLEX CONTROL UNIT; PRISMAFLO BLOOD WARMER