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 Problems Abdominal Pain (1685); Hemolysis (1886)

Event Date 01/31/2014

Event Type  Injury  

Event Description

A patient with a history of gallstones and uti developed abdominal pain during the dialysis treatment.The abdominal pain increased thought out the treatment.The patient was hospitalized and reported to have hemolysis, bacteremia and dic.Several days later the patient expired.Phoenix machine performed per manufacturer's specifications.The cartridge blood tubing set and revaclear dialyzer.Were discarded and not available for investigation.

Manufacturer Narrative

The cartridge blood tubing set involved in this incident was discarded by facility and not available for investigation.15 retained blood tubing samples from each lot number reported 1000050661, 1000073430, 1000077272, 1000072623, and 1000072624 were visually inspected, functional, leak, occlusion and dimensional testing was performed and no failures or defects were detected.Gambro has no information to suggest that any gambro product caused or contributed to the incident and gambro does not regard the submittal of this report as an admission of causation or liability.

• 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: 3657253
• MDR Text Key: 4351020
• Report Number: 8030638-2014-00005
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/05/2014,03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 101025
• Device Lot Number: NOT PROVIDED
• 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: 03/05/2014
• Distributor Facility Aware Date: 02/03/2014
• Event Location: Dialysis Unit
• Date Report to Manufacturer: 02/03/2014
• Date Manufacturer Received: 02/03/2014
• 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
• Treatment: PHOENIX SN:(B)(4) SWV:3.36, REVACLEAR DIALYZER
• Patient Outcome(s): Death; Hospitalization; Life Threatening
• Patient Age: 71 YR