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

Model Number N/A

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2017

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

The reporter stated that the customer called the helpline as the prismaflex machine did not alarm when the return line became disconnected from the catheter.There was some blood loss into the bed which was estimated at approximately 200ml.The customer reconnected the return line to the catheter and the machine gave the 'return disconnection alarm'.The machine then presented a 'system failure' alarm.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The issue occurred approximately half an hour after the start of therapy.The patient was continuously monitored by a staff member.The reporter stated that the patient did not physically pull the line.The disconnection issue was noted when another staff member approached the other side of the bed and noticed blood on the patient.The device was evaluated on-site by a technician.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Testing and troubleshooting were performed with no issues noted.Functional testing was performed by dropping the return pressure to zero multiple times.The machine correctly returned a return disconnection alarm after 15 seconds each time.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was not verified.The device was found to operate per specification.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 - 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: 7143248
• MDR Text Key: 96122782
• Report Number: 9616026-2017-00067
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113874
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 86 YR