MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF1400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	107142
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a patient experienced hemolysis during treatment with a prismaflex control unit, a prismaflex hf1400 and a prismaflex m150.At an unknown time during treatment with a prismaflex hf1400, the effluent was observed to be pink.The set was changed to a prismaflex m150.At an unknown time during this treatment, the effluent bag was observed to have a "red-blood looking color".A blood leak detected alarm was not triggered by the control unit.It was reported that the patient experienced a drop in hemoglobin necessitating a blood transfusion.The patient outcome was not reported.No additional information is available.
Additional Manufacturer Narrative
H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.However, based on the information provided by the customer this was a hemolysis event and not an internal blood leak of the filter.The blood leak detector of the prismaflex control unit is designed to detect red blood cells, not hemolyzed blood which explains why no alarm was triggered during the first treatment.Based on the available information it is undetermined if the set caused or contributed to the suspected hemolysis.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX HF1400
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11538880
• Report Number: 8010182-2021-00107
• Device Sequence Number: 2965954
• Product Code: KDI
• UDI-Device Identifier: 07332414069315
• UDI-Public: (01)07332414069315
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 107142
• Device Lot Number: 20I2405
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRISMAFLEX M150 SET; PRISMAFLEX MACHINE
• Outcome Attributed to Adverse Event: Required Intervention