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

Catalog Number 03-2722-9

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

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

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A user facility reported a blood leak during the initiation of treatment.When the patient's blood flow rate was raised to 450, the venous chamber began to fill up and the transducer separated.The tubing attached to the venous chamber then separated, causing blood to leak out.Dialysis treatment was stopped, the patient was moved to another machine and able to successfully finish treatment.There was no medical intervention required and no adverse effects were experienced by the patient.An estimated blood loss of 30-50ml was reported.No sample was not available as the tubing was immediately discarded due to being contaminated with patient's blood.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and field service was not requested, therefore, the failure mode cannot be confirmed.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 NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331; parque industrial reynosa; reynosa ; MX
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; industrial reynos, bldg. ii; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5096474
• MDR Text Key: 26612343
• Report Number: 8030665-2015-00437
• 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
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 15HR01203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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: 80 YR
• Patient Weight: 84