MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number ASKU

Device Problem Disconnection (1171)

Patient Problems Cardiac Arrest (1762); Blood Loss (2597)

Event Date 09/04/2020

Event Type  Injury  

Manufacturer Narrative

The event was reported to have occurred "in the last few months." the device was an unknown prismaflex set facility name: (b)(6) medical center.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient's return blood line became disconnected from the catheter during continuous renal replacement therapy using a prismaflex set and a prismaflex control unit.During nursing handoff at beside, the patient's blood pressure was observed to be dropping.Upon assessing the patient, "a large amount of blood" was observed on the bed.The patient went into cardia arrest and needed resuscitation.The patient outcome was not reported.An alarm was not generated by the control unit.No additional information is available.

Manufacturer Narrative

D1: device was an unknown prismaflex m150.B5: it was reported that no issues were noted on the catheter nor on the involved prismaflex set.It was also reported that no devices were connected between the catheter and the return line.It was reported that the catheter and the patient were both covered with sheets.After resuscitation attempts, spontaneous circulation was achieved.B7: it was reported that the patient was later transitioned to comfort care due to other unspecified clinical findings and subsequently passed away.The exact time and cause of death was unknown.It was not reported if an autopsy was performed.The cause of death was not reported.H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10627552
• MDR Text Key: 209846377
• Report Number: 8010182-2020-00199
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/05/2020,11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2020
• Distributor Facility Aware Date: 09/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2020
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX MACHINE; PRISMAFLEX MACHINE
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR