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

Catalog Number 955052

Device Problems No Audible Prompt/Feedback (2282); Failure to Infuse (2340)

Patient Problem Injury (2348)

Event Date 07/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6). Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous renal replacement therapy (crrt) using a prismaflex control unit, the calcium pump stopped without triggering an alarm. The patient did not receive the calcium infusion for 10 hours. Once the issue was noted, the operator initiated a calcium replacement with an external pump. Treatment was discontinued. It was reported ¿after hours¿ the change calcium syringe button was pushed and the pump ¿work normally¿. There was no report of patient injury associated with this event. No additional information is available.

Manufacturer Narrative

A sample was not received for evaluation. The event history log was analyzed and it was noted that during treatment a syringe change procedure was performed six hours after treatment started, another syringe change procedure was performed ten hours later. The analysis revealed that no calcium was delivered between the change syringe procedures. The treatment was continued with the syringe pump running, without any further syringe issue until treatment stopped five hours later due to warning alarm ¿ extremely negative. Ten three hour long simulated treatments with rca anticoagulation and a syringe change within ten minutes of the first self-test were performed on a control unit in the baxter workshop, and no issues were observed during therapy. The reported condition was verified. The cause of the condition was not determined. A nonconformance has been opened to address this issue. 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
• MDR Report Key: 7848197
• MDR Text Key: 119281377
• Report Number: 9616026-2018-00015
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 955052
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 09/05/2018 Patient Sequence Number: 1