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

Catalog Number 101025

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemolysis (1886)

Event Date 06/03/2017

Event Type  Injury  

Event Description

This is a report of a patient who was admitted to the hospital due to hemolysis following hemodialysis therapy using the phoenix machine, revaclear max dialyzer, and gambro cartridge blood lines.The patient was cannulized with a 15 gauge back-eye needle.The line was primed with normal saline.Approximately 3 minutes after treatment began, the circuit clotted.There was no alarm and no discoloration of the effluent noted at any time during therapy.It was not reported whether the blood in the circuit was returned.The patient was able to complete therapy, but reported experiencing diarrhea during and following treatment.Approximately eight hours later, the patient presented to the emergency room and was admitted to the hospital due to hemolysis.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: 6723342
• MDR Text Key: 80380029
• Report Number: 8030638-2017-00018
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2017,08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 101025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2017
• Distributor Facility Aware Date: 06/22/2017
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/18/2017
• Date Manufacturer Received: 07/24/2017
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR