MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE CUSTOM COMBI SET

Catalog Number 03-2722-9

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/20/2015

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 user facility reported during treatment a blood leak occurred.The leak was reported to be an external leak located on the combi-set bloodline.The machine did not alarm.Estimated blood loss was 80.5cc.The patient had no adverse effects and no medical intervention was required.The patient completed treatment.Sample is available for manufacturing evaluation and has been requested.

Manufacturer Narrative

Visual examination confirmed the alleged problem.An actual sample was received for evaluation.During visual examination, a cut was noticed on the port of the venous chamber.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 spec.

• Brand Name: CUSTOM COMBI SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; reynosa plant; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; 1331 parque industrial; reynosa, tamaulipas CP 88 780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999751
• MDR Report Key: 4999703
• MDR Text Key: 22989687
• Report Number: 8030665-2015-00350
• 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: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Followup
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2018
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 15DR01201
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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: 60 YR
• Patient Weight: 80