MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF1000; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	107140
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during treatment with a prismaflex hf1000 set, ¿high access pressure, filter pressures 300, air bubbles in filter line, and deaeration chamber¿ alarms were generated and treatment was ended without the extracorporeal blood being returned to the patient.It was further reported that the event occurred three (3) times and the ¿tubing connectors were not connected correctly on the tubing¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The actual device was not available; however, a companion sample was received for evaluation.Visual inspection of the companion sample did not identify any abnormalities that could have contributed to the reported condition.No product malfunction was identified on this companion sample.The reported condition was not verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX HF1000
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEYZIEU; 7, av lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12647612
• Report Number: 8010182-2021-00319
• Device Sequence Number: 19206138
• Product Code: KDI
• UDI-Device Identifier: 07332414069254
• UDI-Public: (01)07332414069254(10)
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K042938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 107140
• Device Lot Number: 21C1705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male