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

Catalog Number 114510

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Hemolysis (1886)

Event Date 12/27/2013

Event Type  Injury  

Event Description

The customer reported that shortly after the dialysis treatment was initiated, the phoenix machine generated the heparin rate error alarm.The patient was temporarily disconnected and the system was cleared.The patient was reconnected and therapy was resumed.After resuming therapy another heparin rate error alarm was generated.The nurse deactivated the heparin administration and treatment continued with no additional alarms.At the completion of therapy, the patient was showing symptoms of hemolysis and was admitted to icu.The phoenix machine was inspected by a gambro technical services representative and was found to be performing within manufacturer's specifications.The cartridge blood line with hemoscan and revaclear dialyzer were discarded and not available for investigation.

Manufacturer Narrative

The blood tubing set involved in this incident was not available for investigation.(b)(4) retained blood tubing samples from same lot number reported 1000074089 were visually inspected and functional, leak occlusion and dimensional testing were performed and no failures or defects were detected.The involved blood tubing set does not have fda clearance but is similar to a blood tubing set with fda clearance.

• 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: 3590532
• MDR Text Key: 4035899
• Report Number: 8030638-2014-00003
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2016
• Device Catalogue Number: 114510
• Device Lot Number: 1000074089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2013
• 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
• Treatment: PHOENIX SN (B)(4), REVACLEAR 300.
• Patient Outcome(s): Hospitalization