MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CUSTOM COMBI SET W/SPLIT SEPTUM

Catalog Number 03-2621-5

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/12/2015

Event Type  malfunction  

Manufacturer Narrative

Plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

Event Description

A hemodialysis inpatient user facility reported during treatment a blood leak occurred.The leak was caused by the wrong product being used.During set up, the nurse noticed the saline line was not attached as it usually is.The machine was tested and all tests passed.The patient was placed on the machine where the arterial pressure remained positive and the venous pressure went up to 300.The machine alarmed that there was air in the line.The blood was not able to be rinsed back due to air in the line.Estimated blood loss was 250cc.The patient had no adverse effects and no medical intervention was required.The patient completed treatment on a different machine with a new set-up.Sample has been requested.

Manufacturer Narrative

Because the complaint sample was not available for evaluation, no analysis was performed.The complaint is deemed as not confirmed.An investigation of the device manufacturing records was also conducted by the manufacturer.There were no deviations or nonconformances 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 W/SPLIT SEPTUM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer Contact: dianne chin ; 920 winter st ; waltham, MA 02451 ; 7816999105
• MDR Report Key: 5032825
• MDR Text Key: 24295137
• Report Number: 8030665-2015-00381
• 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: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Catalogue Number: 03-2621-5
• Device Lot Number: 15AR01272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 109