MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA; HOME HEMO COMBI SET; ONW

Catalog Number 03-2962-3

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Blood Loss (2597)

Event Date 12/16/2013

Event Type  malfunction  

Event Description

It was reported that a syringe tip dislodged in a patient's venous port which resulted in minimal blood loss.After retransfusion, the entire needle was removed from the port.The patient ended therapy 30 minutes earlier than expected.Patient status was reported as unchanged.A sample is not available for evaluation.In follow-up conversation with the nurse, it was stated they would prefer better material for the venous port where the needle is inserted.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.

• Brand Name: HOME HEMO COMBI SET
• Type of Device: ONW
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA;; cd, reynosa, tamps ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; brecha e99 sur; parque; industrial reynos, bldg. ii; cd, reynosa, tamps CP 8 8780; MX CP 88780
• Manufacturer Contact: tanya taft,rn,cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999105
• MDR Report Key: 4768545
• MDR Text Key: 20075109
• Report Number: 8030665-2015-00238
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2014
• Device Catalogue Number: 03-2962-3
• Device Lot Number: 13HR01014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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: FRESENIUS 2008K@HOME HEMODIALYSIS MACHINE.
• Patient Age: 72 YR