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

Catalog Number 105762

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event 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.

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
• Type of Device: SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10228296
• MDR Text Key: 198095771
• Report Number: 1416980-2020-03719
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414048914
• UDI-Public: (01)07332414048914
• Combination Product (y/n): Y
• PMA/PMN Number: K801016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 105762
• Device Lot Number: 19J28T028
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 07/03/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX MACHINE; PRISMAFLEX SET