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

Model Number CUSTOM COMBISET

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

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

Event Date 08/21/2015

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 w/10 minutes of treatment remaining, while the patient's blood was being returned.The patient's dialysate flow rate during treatment was 800 ml.The blood leak was observed at the tubing on top of the connection of the saline line to the arterial line.The arterial line was visibly seen separating, w/blood leaking out.There was no machine alarm reported.The treatment was halted and the machine was not restrung, as the patient was at the end of their treatment.No adverse symptoms were exhibited and no medical intervention was required.Due to the malfunction, however, the patient lost an estimated 200 ml of blood.Treatment.

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; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque ind. reynosa sur, brecha e99 ; apartado postal #326; reynosa, tamps CP 88 780; MX CP 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451 ; 7816999751
• MDR Report Key: 5079817
• MDR Text Key: 26047059
• Report Number: 8030665-2015-00421
• 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: 06/01/2018
• Device Model Number: CUSTOM COMBISET
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 15HR01257
• 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: 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: 31 YR
• Patient Weight: 76