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 No Consequences Or Impact To Patient (2199)

Event Date 06/20/2018

Event Type  malfunction  

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 several hours. Once the issue was noted, the operator ¿gently touched¿ the syringe pump and an error message was triggered. The extracorporeal blood was not returned to the patient. Treatment was discontinued. There was no report of 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 22643 ; SW 22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7845860
• MDR Text Key: 119802971
• Report Number: 9616026-2018-00014
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/05/2018
• 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?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/12/2018
• 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