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

Catalog Number 955595

Device Problems Improper or Incorrect Procedure or Method (2017); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2023

Event Type  malfunction  

Event Description

It was reported that during use with one unit of prismaflex m100 set, an internal air leakage at the arterial end was observed.The treatment was terminated without returning the extracorporeal (ec) blood to the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Initial reporter address: (b)(6).The actual sample was not available; however, a photograph and video of the sample were provided for evaluation.Visual inspection observed air bubble in the access line.The reported condition was verified.It also identified that the line between the catheter and the access line is clamped.As the line between the catheter and access is clamped, and the blood pump is still running, it created air in the access line by cavitation.The cause of the condition was due to misuse of the set.The control unit should also present an alarm due to the air bubble detector.The return clamp line on the control unit also prevents air from passing to the patient.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Per the gui, the access and return lines should be always connected directly to the catheter/ blood access device.No additional devices between the return line and the blood access device should be connected.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 SETS (M)
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEYZIEU; av lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16531603
• MDR Text Key: 311328657
• Report Number: 8010182-2023-00067
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414124397
• UDI-Public: (01)07332414124397
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2023

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 Catalogue Number: 955595
• Device Lot Number: 22G0080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX MACHINE