MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EFFLUENT BAG; SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES

Catalog Number	107650
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
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 from two (2) 9l effluent bags during continuous renal replacement therapy.The leak was observed to be coming from a gap at the bottom of the bag next to the drain (which was appropriately clamped with both incidences).It was reported the leak was very slow while the bag was hanging on the scale but flowed much faster when the partially filled bag was removed and the drainage port was moved to the side (making the gap into a wider hole in the bottom of the bag).It was reported the nurse noticed the leak and changed the bags prior to the machine alarming.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: one actual sample and one companion sample were returned for evaluation.Both samples were filled with water and left to hang: both bags leaked from the junction of the tube to the bag.The reported condition was verified.The cause was product assembly related.A batch review 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: EFFLUENT BAG
• Common Device Name: SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10511095
• Report Number: 1416980-2020-05547
• Device Sequence Number: 19709877
• Product Code: MON
• UDI-Device Identifier: 07332414075828
• UDI-Public: (01)07332414075828
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020
• Report Date (Section F): 09/09/2020

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: 12/31/2020
• Device Catalogue Number: 107650
• Device Lot Number: 20A24V173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/06/2020
• 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: HF1000 SET; PRISMAFLEX MACHINE
• Date Report Sent to FDA: 09/09/2020