MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER REVACLEAR 300; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	114745
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Headache (1880); High Blood Pressure/ Hypertension (1908)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a hemodialysis patient was three minutes into treatment with a revaclear 300 dialyzer when a tmp alarm was generated by the machine.After observation, particles were observed in the dialyzer.The patient was disconnected from the set.It was reported the patient experienced a headache and high blood pressure.The patient received an unspecified medication for the high blood pressure.Treatment for the headache was not reported.After the treatments, the blood pressure was stabilized and the patient was re-dialyzed in another device.No additional information is available.
Additional Manufacturer Narrative
Upon follow up it was reported there was an unknown type of residue found to be accumulated in the machine, further specified as "water passed though the dialysate inlet and the residue passed into the dialyzer¿, located at "slightly below the dialysate connection point".The reporter stated the event was not related to the dialyzer.Concomitant medical products: fresenius 4008s dialysis machine.The actual device was not available; however, four photographs of the sample were provided for evaluation.The visual inspection of the provided pictures showed the product was found wet.Several yellowish particulate matter were visible in the dialysate side.The reported condition was verified.A batch review was conducted and there was no deviations found related to the reported condition during the manufacture of this lot.The cause of the condition was not determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: REVACLEAR 300
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 8159907
• Report Number: 9611369-2018-00139
• Device Sequence Number: 11256148
• Product Code: KDI
• UDI-Device Identifier: 07332414114916
• UDI-Public: (01)07332414114916
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K130039
• 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): 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 114745
• Device Lot Number: 8-9248-H-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 02/04/2019
• 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: UNSPECIFIED HEMODIALYSIS MACHINE; UNSPECIFIED HEMODIALYSIS MACHINE
• Outcome Attributed to Adverse Event: Required Intervention