MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE 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 08/21/2015

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 a blood line separated during treatment which leak to minor blood loss.The separation occurred by the anastomosis at the end of treatment, during blood return.The bloodline was clamped off once the separation was recognized and the remaining blood was not returned.Estimated blood loss was 200 ml.The pt did not experience any adverse effects and no medical intervention was required.A sample has been returned to the mfr for eval.

Manufacturer Narrative

The actual device was not returned to the manufacturer for physical evaluation.An alternate sample from the same lot was pulled from stock for investigation.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 ; cd, reynosa, tamps ; MX
• Manufacturer (Section G): REYNOSA PLANT, ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331; cd, reynosa, tamps ; MX
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street ; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5052717
• MDR Text Key: 24912147
• Report Number: 8030665-2015-00389
• 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: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 80