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 03/24/2017

Event Type  Injury  

Event Description

Reportedly, approximately two hours after treatment start, the patient complained of a heat sensation.The ultrafiltration rate was stopped, an unspecified amount of saline was provided and the dialysis fluid temperature reduced to 36 degrees c; however, the patient then became disoriented.Another 300ml of saline was provided and the treatment was terminated with blood return.In addition, patient received oxygen therapy and was transfused the next day.Blood sample was taken and the laboratory tests confirmed the presence of hemolysis.The patient was transferred to the emergency unit at the hospital where remained hospitalized for fourteen days.No kinking or anomaly was observed at the level of the blood circuit during 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: 6506522
• MDR Text Key: 73214439
• Report Number: 8030638-2017-00013
• 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
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PHOENIX/INNOVA MACHINE S/N (B)(4)
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR
• Patient Weight: 66