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

Catalog Number 107493

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was evaluated on site.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which included air bubble testing, prime and simulated run.Air bubble testing passed with no issues found.Prime and simulated run verified the air bubble function with no issues found and no repairs needed.The reported condition was not verified.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The cause of the condition could not be determined.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 machine triggered an air in blood alarm.The alarm occurred at an unspecified time during treatment.The cause of the alarm was unknown.It was reported there was no visible air detected and troubleshooting was unsuccessful.Treatment was discontinued.The extracorporeal blood in the circuit was not returned to the patient.There was no report of 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: 8370220
• MDR Text Key: 139585588
• Report Number: 9616026-2019-00007
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 107493
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2019
• Distributor Facility Aware Date: 02/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2019
• Date Manufacturer Received: 02/02/2019
• 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: N
• Patient Sequence Number: 1