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 Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 09/28/2016

Event Type  Injury  

Event Description

Fifteen to thirty minutes into a dialysis treatment, the machine generated the air in blood alarm.A blood leak was observed on the cartridge blood line coming from a 2 inch slit in the blood pump segment.Treatment was ended and the blood in the extracorporeal circuit was not returned to the patient with an estimated blood loss of 188 ml.The patient was transferred to the hospital for overnight observation.The patient was dialyzed the following day.

• 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: luz del sol rodriguez ; blvd. pacifico no. 10014; parque industrial pacifico; tijuana ; MX ; 6646266700
• MDR Report Key: 6052540
• MDR Text Key: 58248118
• Report Number: 8030638-2016-00013
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2019
• Device Model Number: CARTRIDGE
• Device Catalogue Number: 101025
• Device Lot Number: 1000143871
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2016
• Distributor Facility Aware Date: 09/29/2016
• Event Location: Dialysis Unit
• Date Report to Manufacturer: 10/24/2016
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2016
• 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: PHOENIX SN:(B)(4)
• Patient Outcome(s): Hospitalization