MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS S.A. DE C.V. CARTRIDGE

Model Number 103402

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemolysis (1886); Low Blood Pressure/ Hypotension (1914); Pain (1994); Blood Loss (2597)

Event Date 03/13/2015

Event Type  Injury  

Event Description

A pt in (b)(6) was undergoing a dialysis session which included a cartridge bloodline.Approximately an hour into treatment, the patient's venous and arterial pressures dropped and did not change despite the nurse performing the diaphragm repositioning procedure.Treatment continued for another hour and the venous side of the circuit clotted.The pt had an estimated blood loss of 200 ml when only a portion of the blood in the extracorporeal circuit was returned.Following rinse back, the pt developed severe dorsal pain and the pt was transferred to the emergency room.The pt was admitted to the hosp with a diagnosis of hemolysis which was confirmed with a peripheral blood smear, haptoglobin, and blood schistocytes.The patient's hemoglobin dropped to 50 g/dl and 2 units of packed red blood cells (prbcs) were given.The pt was discharged from the hosp one week later.

Manufacturer Narrative

The cartridge blood line was discarded and not available for analysis.The lot number was not provided, therefore, no review of the device history record or the complaint record could be performed.

• Brand Name: CARTRIDGE
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS S.A. DE C.V.; tijuana ; MX
• Manufacturer Contact: ramon ruiz ; blvd. pacifico no. 10014; parque industrial pacificao; tijuana ; MX ; 645124212
• MDR Report Key: 4778519
• MDR Text Key: 5819279
• Report Number: 8030638-2015-00004
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 103402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2015
• 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
• Patient Sequence Number: 1
• Treatment: PHOENIX
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR