MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX TPE; SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA

Catalog Number	114093
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2019
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 after starting therapeutic plasma exchange (tpe) treatment using four prismaflex tpe sets, clotting siting ¿access issues¿ was observed.It was reported that access was intact and patent.It was reported treatment was started with -50 to -80 and after five to ten minutes, the access would jump to over -250.Treatment was discontinued, and the extracorporeal (ec) blood was returned to the patient after the first event; however, it was unknown if the ec blood was returned for the subsequent events.It was reported a new tpe2000 was prepared; however, the event occurred again with "one to two filter sets".A tpe2000 set with a different lot number was then prepared and treatment was successfully completed.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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.
Additional Manufacturer Narrative
Correction: removal of information in section f related to importer - the initial report inadvertently included the importer report number.This mdr should have been submitted only with the mfr.Number (and not as importer).

• Brand Name: PRISMAFLEX TPE
• Common Device Name: SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9507114
• Report Number: 8010182-2019-00219
• Device Sequence Number: 2982073
• Product Code: MDP
• UDI-Device Identifier: 07332414111038
• UDI-Public: 07332414111038
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 12/18/2020
• Report Date (Section F): 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: 114093
• Device Lot Number: 19A1504
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2019
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 01/06/2020; 12/17/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/29/2020; 12/18/2020
• 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: ALBUMIN; CITRATE; PRISMAFLEX MACHINE; TRIALYSIS CATHETER 12 FRENCH15CM
• Date Report Sent to FDA: 12/20/2019