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

Catalog Number 955052

Device Problems Failure to Infuse (2340); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6). An event history log analysis was performed and showed that no calcium was delivered between the change syringe procedures. The reported condition was verified. The cause of the reported condition could not be determined. A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event. A nonconformance has been opened to address this issue. Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a prismaflex machine experienced a malfunction general system failure (6). This alarm occurred during patient therapy and while the nurse attempted to change the calcium syringe. The nurse attempted to change the calcium syringe as the patient required an increase of calcium compensation up to 150%. The calcium kept falling and it was noticed that the calcium syringe was still full and was not infused into the patient for 12 hours with no syringe related alarms that occurred. It was further clarified that machine was continued to be in use after the event and working as expected. However, after analysis of the device history logs, it was determined that no calcium was delivered to the patient. There was no patient injury or medical intervention associated with this event. 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 SE-22 643; SW SE-22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8092242
• MDR Text Key: 128412476
• Report Number: 9616026-2018-00024
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/20/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 955052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 10/26/2018
• 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