MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE N. AMERICA.V. CUSTOM COMBI SET

Model Number CUSTOM COMBI SET

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

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

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

The device has 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 dialysis user facility reported a blood leak during treatment initiation.The blood leak was observed at the anastomosis of the intravenous line.It was suspected to be the result of a faulty joint seal.There was no machine alarm reported.The patient's dialysate flow rate during treatment was 800 ml.The treatment was halted, the machine was restrung, and the pt was able to successfully finish treatment w/no adverse symptoms.Medical intervention was not required.Due to the malfunction, however, the patient lost an estimated 120 ml of blood.

Manufacturer Narrative

The actual device was not returned to the manufacturer for physical evaluation, however, a companion sample from the same lot was returned for investigation and no defects or irregularities were noted.In addition, 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 N. AMERICA.V.; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque ind. reynosa sur, brecha e99 ; apartado postal #326; raynosa, tamps CP 88 780; MX CP 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451 ; 7816999751
• MDR Report Key: 5079816
• MDR Text Key: 26046559
• Report Number: 8030665-2015-00420
• 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: Followup
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• 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 Model Number: CUSTOM COMBI SET
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 15JR01297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2015
• 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
• Patient Age: 80 YR
• Patient Weight: 89