MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CUSTOM COMBI SET

Catalog Number 03-2722-9

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

Plant investigation has not yet been completed.The device lot number is unavailable after being requested from the biomedical tech, as the device has been discarded.A f/u report will be filed upon completion of the investigation.

Event Description

A user facility reported that at the end of a patient treatment, the combiset tubing developed a small leak at the site where the heparin tubing connects (heparin line not in use at the time).The main tubing was clamped and the heparin section of the tubing fell off.A pt was receiving treatment at the time of the leak, an estimated 20ml of blood loss occurred.No harm to the pt occurred and no medical intervention was needed.The treatment was at the completion stage and pt completed treatment on the same machine with original tubing.The tubing was discarded.The pt continues on hemodialysis without further issue.

Manufacturer Narrative

Complaint sample was not available for evaluation to confirm the alleged product malfunction.Sales and shipping search to the patient within a three month time frame prior to the date of occurrence was done.According to sap all product has been sold or distributed and not available for testing.Therefore the complaint is deemed as not confirmed.A batch record review was conducted and confirmed there were no deviation or non-conformances during the manufacturing process.Product labeling, material, and process controls were within specifications.

• Brand Name: CUSTOM COMBI SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; brecha e99 sur; parque; industrial reynos, bldg. ii; cd, reynosa, tamps 88780 ; MX 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5346857
• MDR Text Key: 35623134
• Report Number: 8030665-2015-00621
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Other Device ID Number: 00840861100293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2015
• 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
• Patient Age: 77 YR
• Patient Weight: 107