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 Pump (1502); Failure to Infuse (2340); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during treatment with a prismaflex machine, a malfunction of the calcium syringe occurred.The treatment type was regional citrate anticoagulation.The syringe containing calcium was replaced as planned.The calcium was to be delivered at approximately 8-9 ml/hr.However, approximately six hours after the syringe replacement, the supervising nurse found that the syringe was still full and therefore no calcium was delivered to the patient via the linear pump during this time interval.The nurse exchanged the syringe using the "change syringe" routine and found out that after this procedure, calcium was once again delivered in a regular manner.The treatment was switched to another prismaflex control unit later the same day.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was returned to a baxter workshop for analysis.The treatment history files were reviewed and revealed that two change syringe procedures had been performed on the date of the event.Further analysis revealed that no calcium was delivered between the change syringe procedures.The reported issue could not be duplicated using the current released software.Ten three hour long simulated treatments with rca anticoagulation and a syringe change within ten minutes of the first self-test have been performed on the control unit in the baxter workshop with no issues noted.A device history review revealed no issues that could have caused or contributed to the reported issue.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 7074640
• MDR Text Key: 94559415
• Report Number: 9616026-2017-00065
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1