MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M60 SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	106696
Medical Device Problem Codes	Fluid/Blood Leak (1250); Hole In Material (1293)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 a prismaflex m60 set clotted during use, and blood leaked from the pbp tubing.The filter clotted at the pbp line, where it wraps around the blood pump.After the set clotted, the reporter noticed a leak from what appeared to be a tiny pin hole in the tubing.Treatment was stopped and the patient was disconnected.The blood in the circuit was not returned to the patient.The patient had minimal blood loss.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: PRISMAFLEX M60 SET
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu cedex rhone
• MDR Report Key: 7360091
• Report Number: 8010182-2018-00017
• Device Sequence Number: 1470631
• Product Code: KDI
• UDI-Device Identifier: 07332414064549
• UDI-Public: (01)07332414064549
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K041005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/21/2018
• Report Date (Section F): 03/21/2018

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: 08/01/2019
• Device Catalogue Number: 106696
• Device Lot Number: 17H2803
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/21/2018