MAUDE Adverse Event Report: BAXTER HEALTHCARE - OPELIKA REVACLEAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The three samples were 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 three revaclear dialyzers presented an internal blood leakage.The reporter stated that immediately after starting therapy, the non-baxter machine presented a ¿blood leak detected¿ alarm.The treatment was stopped and the blood in the circuit was not returned to the patient.A second dialyzer was then set up on the same machine; again, the machine alarmed.Treatment was stopped, and the blood from the second dialyzer was also not returned to the patient.The nurse moved the patient to a different non-baxter dialysis machine.Within minutes of starting the treatment, the machine presented a ¿blood leak detected¿ alarm.The third setup was taken down and the blood was not returned to the patient.The patient was then set up a fourth time with a dialyzer of a different lot number, and was able to successfully complete therapy.Upon further review by the customer, the three leaking dialyzers were found to have come from a damaged box.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
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: REVACLEAR
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - OPELIKA; opelika AL
• MDR Report Key: 7423457
• Report Number: 3006552611-2018-00004
• Device Sequence Number: 1093785
• Product Code: KDI
• UDI-Device Identifier: 07332414101695
• UDI-Public: (01)07332414101695
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K072232
• 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,Followup
• Report Date (Section B): 05/15/2018

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: 02/10/2020
• Device Model Number: N/A
• Device Catalogue Number: 110633
• Device Lot Number: C418103701
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR