MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION GAMBRO BLOODLINE ACCESSORIES; SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES

Catalog Number	105762
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an external fluid leak was observed during patient treatment from a crack of the luer connector of the accessory line gmb-sp127 - y connector.A ¿flow problem¿ alarm was triggered by the prismaflex machine.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Correction: d4: lot #: the involved lot number was not confirmed.It was reported lot #s 18k097331 and 19j28t028 were in use at the time of the reported event.Lot # 18k09t331 was manufactured on nov 17 2018.Lot # 19j28t028 was manufactured on oct 08 2019.H10: the actual device was not available; however, a retained sample was provided for evaluation.Visual inspected did not reveal any obvious damage.The retention samples were also gravity tested and leak tested under water and no leak was observed.The reported condition was not verified.A batch review of both lots 18k097331 and 19j28t028 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.

• Brand Name: GAMBRO BLOODLINE ACCESSORIES
• Common Device Name: SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10228296
• Report Number: 1416980-2020-03719
• Device Sequence Number: 536460
• Product Code: FJK
• UDI-Device Identifier: 07332414048914
• UDI-Public: (01)07332414048914
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K801016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2020

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: 09/30/2022
• Device Catalogue Number: 105762
• Device Lot Number: 19J28T028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 08/03/2020
• 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; PRISMAFLEX SET