MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE CUSTOM COMBI SET

Catalog Number 03-2722-9

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 10/06/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility has reported that during treatment the custom combi set bloodlines had an occlusion.The patient experienced blood loss due to the lines not being rinsed back.The estimated blood loss was 250 ml.The patient had no adverse effects and no medical intervention was required.The patient completed treatment with a new set up.Sample has not been returned to manufacturer.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.According the sap system no product is available from the distribution centers to be analyzed.The entire lot has been sold and distributed.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

• Brand Name: CUSTOM COMBI SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331; parque industrial; cd, reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: dianne chin ; 920 winter st.; waltham, MA 02451-1457 ; 7816999105
• MDR Report Key: 4289325
• MDR Text Key: 5082544
• Report Number: 8030665-2014-00853
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2017
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 14KR01030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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
• Patient Age: 48 YR