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

Catalog Number 107493

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device was returned for evaluation.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.An event history review revealed no issues that could have caused or contributed to the reported issue.No malfunction of the prismaflex control unit has been identified in this analysis.Return pressure was stable for the last two hours prior to treatment end without any indication of a pressure drop indicative of a return disconnection event.A sample analysis was performed on the device.A loaded test set and primed set verifying device was performed and it passed prime tests.A simulated treatment was performed and it verified device passed periodic self-test.The device was running as per manufacture specification.The cause of the event 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 treatment with a prismaflex machine and prismaflex set, the return line became disconnected from the patient without triggering an alarm.The patient had a large amount of blood loss (amount not specified) resulting in a decrease in hematocrit (hct) by 4 points.The required treatment for the event was to increase monitoring of the patient and blood draw requirements to follow hct levels.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: 8478769
• MDR Text Key: 140781080
• Report Number: 9616026-2019-00018
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 107493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/03/2019
• Distributor Facility Aware Date: 03/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2019
• Date Manufacturer Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: PRISMAFLEX M150 SET
• Patient Outcome(s): Required Intervention