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

Model Number 101323

Device Problem Circuit Failure (1089)

Patient Problems Abdominal Pain (1685); Hemolysis (1886); Complaint, Ill-Defined (2331)

Event Date 08/05/2015

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for analysis.The technical investigation is ongoing.

Event Description

A patient in (b)(6) was undergoing a dialysis session on an innova machine with an innova cartridge blood line, and bicart.Within a few minutes of treatment, the patient developed a strange taste, abdominal pain and had the urge to use the bathroom.During recirculation, the blood in the circuit turned dark and appeared to have clotted or hemolyzed.Treatment was restarted and completed on a different machine and the patient was discharged home following treatment.Later, the patient was admitted to the hospital with suspected hemolysis.

• 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 Contact: ramon ruiz ; blvd. pacifico no. 10014; parque industrial pacifico; tijuana ; MX ; 6646266700
• MDR Report Key: 5057731
• MDR Text Key: 25061380
• Report Number: 8030638-2015-00008
• 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: foreign
• Reporter Occupation: Health Professional
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 101323
• Device Lot Number: 1000087418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2015
• 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: INNOVA
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 80