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 11/10/2016

Event Type  Injury  

Event Description

A patient was undergoing a dialysis treatment on a phoenix machine with a cartridge blood line and revaclear 300 dialyzer.Approximately 90 minutes into the treatment the patient developed nausea, hypertension and shortness of breath.The spent dialysate tested positive for presence of blood and the blood sample drawn was hemolyzed.Treatment was ended.The patient was admitted to the hospital.An ekg was normal and the hemoglobin and hematocrit levels were stable.The antibiotic was discontinued as hemolysis is a known side effect.The patient was discharged the next morning after lab values stabilized and the symptoms resolved.The phoenix (b)(4) was inspected and found to be operating within manufacturer specifications.The disposables were discarded and not available for analysis.The cause of the hemolysis is unknown although it is suspected to be caused by the antibiotic.

• 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: 6123203
• MDR Text Key: 60744618
• Report Number: 8030638-2016-00017
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/22/2016

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: Health Professional
• 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: 11/22/2016
• Distributor Facility Aware Date: 11/10/2016
• Event Location: Dialysis Unit
• Date Report to Manufacturer: 11/22/2016
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 300 DIALYZER
• Patient Outcome(s): Hospitalization