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

Catalog Number 107493

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tachycardia (2095); Twitching (2172)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after continuous veno-venous hemofiltration treatment using a prismaflex control unit, a prismaflex set and a prismasol bag, an intensive care unit patient experienced tachycardia and a facial and toe twitch. It was reported while the patient was connected, the blood backed up from the deaeration chamber. After the blood was returned, a new set was primed. Shortly after treatment started, the control unit generated a flow problem alarm. The control unit alarmed 14 times in total. The treatment was stopped with partial blood restitution (140 of 189 ml returned). The total amount blood loss was estimated as 330ml. Approximately 20 min after treatment ended, the patient experienced tachycardia, reported as ¿150s¿ and a facial and toe twitch. No further detail was provided regarding any medical interventions for the events. At the time of this report, the patient remained in the icu and the patient¿s 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 - LUND MONITORS; lund skane lan
• Manufacturer (Section G): BAXTER HEALTHCARE - LUND MONITORS; magistratsvagen 16; lund skane lan 22643 ; SW 22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8395241
• MDR Text Key: 137979047
• Report Number: 9616026-2019-00010
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 107493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 03/06/2019 Patient Sequence Number: 1

Treatment

PRISMAFLEX ST150 SET; PRISMASOL 0 BAG