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

Model Number 114598

Device Problem Insufficient Information (3190)

Patient Problem Abdominal Pain (1685)

Event Date 06/05/2015

Event Type  Injury  

Event Description

A patient in (b)(6) went to the hospital with abdominal pain the day following a hemodialysis session that included an innova cartridge blood line.The blood sample taken from the patient was hemolyzed and the patient¿s hgb was decreased 2.5 g/dl.According to the information provided the patient was not hospitalized and did not receive a blood transfusion.The innova cartridge blood line was discarded and not available for analysis.

Manufacturer Narrative

The innova cartridge blood line is similar to cartridge blood line with 510 (k) approval - k070414.The innova cartridge blood line was discarded and not available for analysis; 20 retained samples from lot number 1000087417 were visually analyzed and there were no obstructions or kinks.The dhr for this lot was reviewed and there were no manufacturing anomalies.In addition, the complaint database was reviewed and there were no similar complaints associated with this lot number.The root cause of the hemolysis is not known.

• 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: 4899559
• MDR Text Key: 21058380
• Report Number: 8030638-2015-00006
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 114598
• Device Lot Number: 1000087417
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 53