MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF1400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	107142
Medical Device Problem Codes	Disconnection (1171); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/06/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a patient who was being treated with continuous renal replacement therapy using a prismaflex control unit, a prismaflex hf1400 filter set and a tego connector (non baxter device) "bleed out" and subsequently passed away.It was reported that in accordance with the facility clinical practice, the tego connector (non baxter device) was connected between the patient catheter (non baxter device) and the return blood lines.Treatment had been running for more than nineteen (19) hours when the return blood line became disconnected from the tego connector.No alarm was generated by the prismaflex control unit as a result of the disconnection.The operator was alerted by a cardiac monitor as the patient presented with bradycardia and the patient had ¿bleed out¿.The nurse responded to the alarm and assessed airway.The red and blue lines of the set were clamped and the machine was stopped.The estimated blood loss was reported as approximately 150-200ml.The patient subsequently passed away.It was reported that an autopsy will be performed.No additional information is available.
Additional Manufacturer Narrative
Additional information added to: d10, h3 and h6.H10: the actual device was returned with the sample full of blood.A visual inspection was performed on all connections.No luer was found broken or cracked and all luers were screwed on properly.A pressure test was performed, with no leak observed.A functional test and a dimensional verification of male luer lock involved was performed with no abnormalities noted.No product malfunction was identified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Based on the information provided by the customer a tego connector was used between the male luer lock of the return line and the patient catheter.The use of this connector is a misuse.The use of connectors may prevent a secure connection between the return line and the patient¿s blood access device.To ensure a proper connection, users must follow the prismaflex operator¿s manual which lists the following warnings: always connect the return line directly to the blood access device.Do not connect additional devices between the return line and the blood access device.The use of additional devices, such as three-way valves, stopcocks, or extension lines, may impair return pressure monitoring.Their use can impede the detection of return disconnections, potentially resulting in severe blood loss.During priming and operation observe the system closely for leakage at joints and connections within the set.Leakage can cause blood loss or air embolism.If leakage cannot be stopped by tightening the connections, replace the set.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
B5: the prismaflex operator¿s manual warns that the use of additional devices between the return line and the blood access device can impair return pressure monitoring and the detection of return disconnections, potentially resulting in severe blood loss.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX HF1400
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9662285
• Report Number: 8010182-2020-00008
• Device Sequence Number: 3602831
• Product Code: KDI
• UDI-Device Identifier: 07332414069315
• UDI-Public: (01)07332414069315
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K042938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2020
• Report Date (Section F): 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2021
• Device Catalogue Number: 107142
• Device Lot Number: 19G1003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/06/2020; 03/05/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 02/04/2020; 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARDIAC MONITOR.; CATHETER.; PRISMAFLEX MACHINE PRODUCT CODE:(B)(4).; TEGO CONNECTOR.; CARDIAC MONITOR; CATHETER; PRISMAFLEX MACHINE PRODUCT CODE: 106913; TEGO CONNECTOR
• Outcome Attributed to Adverse Event: Death
• Patient Age: 65 YR
• Date Report Sent to FDA: 02/03/2020