MAUDE Adverse Event Report: REYNOSA MANUFACTURING FMC BLOODLINES

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility has reported that during treatment, blood loss occurred.The nurse stated that the saline was not clamped, it was left open and air got into the system, tried to re-circulate to get air out and blood clotted due to air.The air detector alarm went off.Blood was not returned to the patient.The nurse stated that there was no blood leak and the patient did not require any medical intervention.Estimated blood loss was 200cc's.Sample has not been returned to the manufacturer.

Manufacturer Narrative

The plant investigation has not yet been completed.A follow up report will be filled upon completion of the investigation.

• Brand Name: FMC BLOODLINES
• Manufacturer (Section D): REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; mike allen 1331; parque industrial reynosa; reynosa, tamaulipas 8878 0; MX 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3897233
• MDR Text Key: 4651168
• Report Number: 8030665-2014-00439
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 05/21/2014
• 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: OPTIFLUX 180NRE DIALYZER FINISHED ASSY; HEMODIALYSIS MACHINE
• Patient Age: 57 YR