MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS S.A. DE C.V. CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number CARTRIDGE

Device Problem Insufficient Information (3190)

Patient Problem Hemolysis (1886)

Event Date 10/29/2016

Event Type  Injury  

Event Description

A hospitalized patient was scheduled for a three hour dialysis treatment.The dialysis treatment included a phoenix machine; cartridge bloodline; and a revaclear dialyzer.According to the nurse, the patient had an av fistula which was easily accessed.At the beginning of the dialysis treatment the nurse noticed the blood in the dialyzer was bright red in color.An hour later, blood was drawn from the patient and found to be hemolyzed.Treatment was stopped and the blood in the extracorporeal circuit was returned to the patient.Treatment was restarted with a new blood line and dialyzer.The blood in the second dialyzer appeared bright red in color.Blood was drawn again and it was reported as hemolyzed.The patient completed the three hour dialysis treatment however, the blood in the extracorporeal circuit was not returned to the patient for an estimated blood loss of 188 ml.The patient¿s hemoglobin had decreased from 11.4 g/dl prior to dialysis to 9.1 g/dl.The cause of the hemolysis remains unknown.

• Brand Name: CARTRIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS S.A. DE C.V.; blvd. pacifico no. 10014; parque industrial pacifico; tijuana ; MX
• Manufacturer (Section G): GAMBRO RENAL PRODUCTS S.A. DE C.V.; blvd. pacifico no. 10014; parque industrial pacifico; tijuana ; MX
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2249487578
• MDR Report Key: 6119340
• MDR Text Key: 60640310
• Report Number: 8030638-2016-00015
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/21/2016

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: No Information
• Device Model Number: CARTRIDGE
• Device Catalogue Number: 101025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2016
• Distributor Facility Aware Date: 11/01/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2016
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PHOENIX MACHINE, REVACLEAR DIALYZER
• Patient Outcome(s): Other