MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX TPE 2000; 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 Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that after a patient completed therapeutic plasma exchange treatment #4, using a prismaflex tpe2000 set, the patient complained of itching and body rash.Albumin solution (2 liter) was used as exchange.The patient was treated for the event with magnesium intravenously (dose not reported) and benadryl intravenously ( dose not reported).The patient later experienced a drop in blood pressure (66/49 mmhg), drop in oxygen saturation (reported as a drop into the 80s) and the patient became unresponsive.Levophed and dopamine ( dose and route of administration was not reported) was administered as treatment.At the time of this report, the patient was reported to be doing well and was on oxygen (per nasal cannula) and treatment with levophed was ongoing (low dose).The patient's rash was reported to be "almost completely resolved".It was also reported the patient also complained of itching one day prior to this event and was treated with benadryl orally (dose not reported.No additional information is available.
Additional Manufacturer Narrative
Additional information added to the f tab.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX TPE 2000
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10416296
• Report Number: 8010182-2020-00131
• Device Sequence Number: 3619556
• Product Code: KDI
• UDI-Device Identifier: 07332414111038
• UDI-Public: (01)07332414111038
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P830063
• Number of Events Summarized: 1
• Summary Report (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): 08/21/2020
• Report Date (Section F): 08/21/2020

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: 03/31/2023
• Device Catalogue Number: 114093
• Device Lot Number: 20D1404
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2020
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 08/21/2020
• 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 MACHINE.
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 08/21/2020