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

Catalog Number 114745

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Hemolysis (1886); Chest Tightness/Pressure (2463)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during home dialysis treatment with a revaclear 300 dialyzer, the patient experienced severe abdominal pain, chest pressure and yellowing of the eyes.The treatment was set to eight (08) hours with a total ultrafiltration (uf) volume of 4500 ml.It was reported that after 4h 40 minutes of treatment, the patient experienced severe abdominal pain.Treatment was discontinued with blood return.The patient allegedly observed the presence of clear blood in the anticoagulant line, but no leakage was reported.The following day, the patient experienced pressure in the chest and their eyes were observed to be "yellowish".The patient went to the emergency room and was treated with 50 mg tramal (tramadol) for stomach ache and the patient returned home the same evening.The patient was diagnosed with hemolysis.No additional information is available.

Manufacturer Narrative

H10: the actual device was received for evaluation.The visual inspection and measurements of the inner diameters were within product specification.The reported condition was not verified.The cause of the reported problem could not be determined.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 300
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10765499
• MDR Text Key: 214150748
• Report Number: 9611369-2020-00148
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K130039
• 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: 12/02/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114745
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AK 98 V2 230V, SELF-CARE.; NOVALINE BL207.; WRO300H.
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR