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

Catalog Number 03-2722-G

Device Problems Fluid/Blood Leak (1250); Misconnection (1399)

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

Event Date 10/03/2015

Event Type  malfunction  

Manufacturer Narrative

The device haas not been returned for physical evaluation.A plant investigation is still ongoing and a supplemental report will be submitted upon completion.

Event Description

An inpatient user facility reported a blood leak during pt treatment.While a pt stated hemodialysis treatment the combi set venous end transducer port became released.The pt care tech indicated the transducer port was wet and the transducer port snapped.There was minimal blood loss as all blood in the line was returned the pt and only traces of blood were left.The pt discontinued treatment and elected not to continue on another hemodialysis unit.No adverse symptoms or other events occurred, there was no pt harm and no medical intervention was required.The sample is not available as the clinic has disposed of it.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.A companion sample was not available for investigation as all lots have been sold and distributed.However, 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 device history review confirmed the labeling, material, and process controls were within specification.

• Brand Name: CUSTOM COMBI SET
• Manufacturer (Section D): FRESENIUS MEDIC AL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque ind. reynosa sur, brecha e-99; apartado postal 326; reynosa, tamps CP 88 780; MX CP 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5194507
• MDR Text Key: 30241441
• Report Number: 8030665-2015-00490
• 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: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Catalogue Number: 03-2722-G
• Device Lot Number: 15JR01222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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