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

Catalog Number	103453
Medical Device Problem Code	Inadequate Ultra Filtration (1656)
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not received for evaluation; however, it was inspected on-site by a baxter qualified technician.Visual inspection and functional tests showed that the hydraulic circuit of the involved phoenix machine was encrusted highly likely by salt crystal deposit and/or debris resulting from drying dialysate fluid.To resolve this situation, the technician performed descaling of the hydraulic circuit as per phoenix operator's manual - chapter 6 "clean/disinfect".This action was able to remove all the encrustation.After complete check including pressures reading, electrovalves test and calibration, they performed a treatment simulation with weight loss of 3 hours and a half without any problem and with an actual target weight loss (twl) equal to the programmed one.The machine was then returned to clinical use without any further similar event reported.The reported condition was verified.Based on the result of the technical inspection by baxter service technician, the cause of the excessive weight removal was confirmed to be the encrustation of the hydraulic circuit of the used phoenix machine.This encrustation was due to incorrect descaling/disinfection scheduling of this customer for this machine.Descaling with vinegar, citric acid or acetic acid is an important process to periodically perform to remove mineral deposits which can also reduce the effectiveness of the weight loss and of the disinfection process.Deposits and/or debris inside the flowmeters of the machine can lead to clog the gears in the flowmeters itself thus leading to error in the ultrafiltration mass balance system of the machine for incorrect flowmeters reading in such a situation.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.
Event or Problem Description
It was reported that during treatment with a phoenix machine, the machine ultrafiltered more than expected.The patient¿s pre-treatment weight was 64,2 kg, and the weight after treatment was 62,8kg, indicating that total weight loss (twl) was 1,4kg, while set twl was 0,5kg.The patient presented with cramps and a bolus of saline was administered (amount of bolus not reported).No additional information is available.

• Brand Name: PHOENIX/INNOVA MACHINES
• 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 - MEDOLLA MODENA MONITORS; via modenese, 66; medolla modena 41036 ; IT 41036
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17031148
• Report Number: 9616240-2023-00006
• Device Sequence Number: 7030308
• Product Code: KDI
• UDI-Device Identifier: 07332414042035
• UDI-Public: (01)07332414042035
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K070643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 103453
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 64 KG