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 03/20/2017

Event Type  Injury  

Event Description

Reportedly, approximately 30 minutes after treatment start, the patient presented with severe abdominal pain.The patient received 300 ml of saline and phloroglucinol.Treatment was discontinued and the blood present within the extra corporeal circuit returned back to the patient.A blood sample was taken and analyzed, confirming the presence of hemolysis.Soon after the event, the patient was transferred to a hospital where a second blood sample was analyzed.Also the result of the second sample confirmed the presence of haemolysis.The patient remained at the hospital for observation in the afternoon and then transferred to a clinic for the following dialysis sessions.No kinking or anomaly at the level of the blood circuit was noticed during this treatment.No additional information is available.

• 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 ; 2242702068
• MDR Report Key: 6506520
• MDR Text Key: 73221625
• Report Number: 8030638-2017-00012
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2019
• Device Model Number: CARTRIDGE
• Device Catalogue Number: 114599
• Device Lot Number: 1000157873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PHOENIX/INNOVA MACHINE PH21610
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Weight: 52