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

Catalog Number 955433

Device Problem Protective Measures Problem (3015)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported a blood leak occurred on a prismaflex machine.Approximately twenty-four hours after the start of continuous renal replacement therapy in continuous venovenous hemodiafiltration, the machine began to frequently alarm ¿the blood leakage detector failed¿ and the machine stopped performing therapy.After five minutes of unsuccessful troubleshooting, the screen would only allow to select the ¿disconnect¿ icon.After communicating with the hospital engineer, the disconnect icon was selected and the screen displayed ¿uninstall¿.The patient was disconnected from the machine without the extracorporeal blood being returned.The patient was infused with two units of leukocyte-depleted suspended red blood cells.The patient lost approximately 178ml of blood.The blood leak detector was cleaned with a dry cotton swab and the machine had no further issues.No additional information is available.

Manufacturer Narrative

H10: the device was not received for evaluation; however, the device was evaluated on site by a non-baxter technician.The technician found the alarm.The reported condition was verified.The technician found the alarm was caused by a dirty/wet tubing path of the blood leak detector.The detector was repaired by cleaning it.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX MACHINES
• 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 - 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: 17952471
• MDR Text Key: 325899720
• Report Number: 9616026-2023-00081
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414123185
• UDI-Public: (01)07332414123185
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/16/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male