MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008

Catalog Number 03-2722-9

Device Problems Failure To Adhere Or Bond (1031); Material Separation (1562)

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

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

The combiset bloodlines were discarded by the user facility and are not available for evaluation.A supplemental report will be submitted upon completion of the plant investigation.

Event Description

The user facility reported that the venous line separated from the patient's needle during treatment which resulted in estimated blood loss of 200ml.The blood was leaking from both the venous line and the patient's access.There was 20 minutes remaining in the patient's treatment.The patient's blood was returned using the same lines.The patient did not experience any adverse effects and no medical intervention was required.

Manufacturer Narrative

Device review: one case of samples from the same lot were received in reynosa from the distribution center for evaluation.The samples were inspected with current drawing and bill of material 03-2722-9 and the product was found to be acceptable.In addition, all bonds were closely reviewed and found to be properly assembled; no abnormalities were detected during visual inspection.The venous patient end connector was found acceptable with no damage.The male conical fitting of the connector was dimensionally inspected with ansi male gauge iso594/1 1986.Samples were found within the acceptable range.One sample was tested on the hemodialysis machine 2008t for simulated use.A batch record review was performed and the batch was found to have met all specifications with no unexpected variances.

• Brand Name: FRESENIUS COMBISET 2008
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; reynosa, tamaulipas CP 88 780; MX CP 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st. ; waltham, MA 02451 ; 7816999751
• MDR Report Key: 5305595
• MDR Text Key: 33791373
• Report Number: 8030665-2015-00595
• 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: Initial,Followup
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 15LR01230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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: 66 YR
• Patient Weight: 51