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 Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 01/08/2015

Event Type  malfunction  

Manufacturer Narrative

The cartridge blood line was discarded and not available for inspection.However, 15 retained blood tubing samples from the same lot ( lot 91000102643) were visually inspected.No fissures, cuts, maceration, gaps, voids or misassembling were detected.The retained samples were also functional and leak tested and no failures and defect were detected.The dhr for this lot was reviewed and there were no manufacturing anomalies.In addition, the complaint database was reviewed there were no other complaints associated with this lot number.The root cause of this event is not known.

Event Description

A patient in (b)(6) was undergoing a dialysis treatment which included a cartridge blood line.At the end of treatment when the nurse was returning the blood in the extracorporeal circuit, the nurse observed an external blood leak from the saline port.The blood loss to the patient was reported to be "minimal".The blood in the extracorporeal circuit was returned to the patient.The patient was not symptomatic and did not require medical intervention as a result of the blood loss.

• 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: cecilia hernandez ; blvd. pacifico no. 10014; parque industrial pacifico; tijuana ; MX ; 6646266700
• MDR Report Key: 5103860
• MDR Text Key: 26959206
• Report Number: 8030638-2015-00009
• 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
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: CARTRIDGE
• Device Catalogue Number: 101025
• Device Lot Number: 1000102643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other