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

Catalog Number	114093
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Muscle Weakness/Atrophy (1967); Nausea (1970); Vomiting (2144); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/16/2022
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 within the first few minutes of therapeutic plasma exchange with a prismaflex tpe2000, a blood leak detector alarm was triggered and an internal blood leak was identified.Visible blood tinged effluent was observed in the effluent line and the drain bag.Visible blood was also observed on the outside of the filter semi-permeable membrane fibers.Treatment was stopped without blood return.A total of 125ml of blood was lost.The patient was stable and the vital signs were normal.Within twenty (20) minutes of starting a new tpe treatment the patient became pale and presented with weakness, nausea and vomiting.The blood pressure reading was 84/43 mmhg.The patient was treated with an unspecified amount of saline.The patient reported they were not feeling well and treatment was interrupted with blood return and another 30 ml saline was provided.The patient 's condition subsequently improved, and the blood pressure increased to 110/60 mmhg.Tpe treatment was suspended for the day.No additional information is available.
Additional Manufacturer Narrative
H10: the actual device was received for investigation.A pressure test was performed, no bubbling, no leak or entry of air was observed.The reported condition was not verified.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.
Additional Manufacturer Narrative
Additional information added to b1, h1 and h10.H10: based on additional information from device evaluation, and review of clinical circumstances surrounding the event, it is possible that the event of patient symptoms requiring medical intervention was associated with the previous blood loss in combination with underlying medical condition and applied treatment parameters when restarting the tpe treatment, therefore, it is unlikely that the prismaflex tpe 2000 caused or contributed to the serious event of patient symptoms.Based on additional information received, prismaflex tpe 2000 was determined not to be a factor in the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX TPE
• 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: 13970927
• Report Number: 8010182-2022-00085
• Device Sequence Number: 4524161
• Product Code: KDI
• UDI-Device Identifier: 07332414111038
• UDI-Public: (01)07332414111038
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PMA P830063
• 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,Followup
• Report Date (Section B): 07/14/2022

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 114093
• Device Lot Number: 21D1404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 04/25/2022; 07/13/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 04/26/2022; 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 12 YR
• Patient Sex: Male