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

Catalog Number 107493

Device Problems No Audible Alarm (1019); Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Date 01/06/2020

Event Type  Death  

Manufacturer Narrative

This is related to mfr report# 8010182-2020-00008.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient was being treated with continuous renal replacement therapy using a prismaflex control unit, a prismaflex hf1400 filter set and a tego connector (non-baxter product).The tego connector was being used in accordance to hospital practice and was attached to the patient's angiodynamics vas-cath which was positioned in the left internal jugular and the vas-cath was reportedly covered by a blanket.Treatment had been running for more than nineteen (19) hours when the prismaflex hf 1400 set (return blood line) became disconnected from the tego connector resulting in blood loss and the patient subsequently passed away.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.No alarm was generated by the prismaflex control unit because of the disconnection.The operator was alerted by a cardiac monitor as the patient presented with bradycardia.The nurse responded to the alarm and assessed airway.The red and blue lines of the set were clamped, and the machine was stopped.It was reported that an autopsy will be performed.No additional information is available.This event is the same event as the one reported through medwatch # 8010182-2020-00008 for the prismaflex hf1400 set.

Manufacturer Narrative

A safety alert has been sent to highlight the importance of following the operator's manual regarding the use of connectors with the prismaflex system.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was inspected on-site by a qualified baxter technician.All pressures and scales were found to be calibrated and met manufacturers' specifications.A treatment simulation was performed with no problems noted.The return line was disconnected from the catheter to simulate the reported event and, as soon as the return pressure dropped below 10 mmhg, the machine properly alarmed "warning: return disconnection" as per design.Hence, the machine could not have contributed to the reported condition.The treatment data files related to the reported event was inspected and it was noted that after about 19 hours of treatment with the last prismaflex set, the prismaflex machine recorded a decrease of the return pressure that passed from about +60-65mmhg to about +15-20mmhg with a minor peak of 13mmhg.This was the moment in which the return line disconnection occurred.Nevertheless, the prismaflex alarm design is structured to alarm with warning: return disconnection when the return pressure falls below +10mmhg.The pressure never dropped below 13mmhg, therefore the return disconnection alarm would not be triggered accordingly.It was reported that user error in accordance with clinical practice of this hospital, where a tego connector (non baxter device) was connected between the patient catheter and the return blood lines and the return blood lines despite a warning given in the prismaflex operators manual.The manual states that the user should ¿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¿.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9667762
• MDR Text Key: 177676882
• Report Number: 9616026-2020-00007
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K072093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2020,04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 107493
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2020
• Distributor Facility Aware Date: 01/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2020
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARDIAC MONITOR; CATHETER; ICU MEDICAL TEGO CONNECTOR; PRISMAFLEX SET- PRODUCT CODE 107142; CARDIAC MONITOR; CATHETER; ICU MEDICAL TEGO CONNECTOR; PRISMAFLEX SET- PRODUCT CODE 107142
• Patient Outcome(s): Death
• Patient Age: 65 YR