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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2018
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 ten minutes into treatment with a prismaflex m60 set , a blood leak at the junction after blood pump tube was observed.Blood was returned to the patient and they were disconnected and treatment ended.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: the actual sample was received for evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Upon visual inspection it was observed that the access line-filter (post pump) was cut near the support plate, resulting in blood leakage.The cause of the event is unknown.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 7707742
• Report Number: 8010182-2018-00092
• Device Sequence Number: 732531
• Product Code: KDI
• UDI-Device Identifier: 07332414064549
• UDI-Public: (01)07332414064549
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K041005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018

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: 11/01/2018
• Device Catalogue Number: 106696
• Device Lot Number: 16K2107
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1