MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA COMBISET ACCESS FLOW REVERSE CON TWISTER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number 03-2794-0

Device Problems Fluid/Blood Leak (1250); Misconnection (1399)

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

Event Date 01/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not yet been returned for physical evaluation.A plant investigation is still ongoing and a supplemental report will be submitted upon completion.

Event Description

An inpatient user facility reported a blood leak during patient treatment from the luer lock connection from the line to the needle, with an estimated patient blood loss of 150cc.Blood was visually observed leaking from the connection site about six minutes into patient treatment and the machine did not alarm.The staff noticed it immediately and the connection was retightened allowing treatment to continue.Fifteen minutes later, the leak occurred again at the same connection site.There was no damage seen on the tubing set.No adverse symptoms or other events occurred and no medical intervention was required.The patient completed treatment on the same machine with a new set-up.The actual sample was available to be sent back for evaluation.

Manufacturer Narrative

The device was returned to the manufacturer for physical evaluation.A visual examination of the returned device found the arterial and venous lines to be acceptable.The venous and arterial patient end connectors were examined and no defects were identified; specifically, collar or taper damage.A dimensional analysis of the male conical fittings of the venous and arterial patient connectors was performed; the dimensional checks were within the acceptable range.The device was then tested using a 2008t hemodialysis machine for simulated use.During the simulated use test, there were no observations of a disconnection or leak from the patient venous and arterial connectors to fistula.The twister was rotated two hours into the test, and no air bubbles occurred in the system.Additionally, no leaks, level variations of venous and arterial chambers, or any alarms were generated during the simulated use testing.The device worked as intended with no noted abnormalities and no defects were identified.A records review was performed on the reported lot.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.The investigation into the cause of the reported problem was not able to confirm the failure mode.The reported defect of connector leak was not confirmed.The complaint device was returned for analysis and the evaluation confirmed that the device functioned fully as designed and met specification.

• Brand Name: COMBISET ACCESS FLOW REVERSE CON TWISTER
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; erika de reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): REYNOSA PLANT; erika de reynosa, s. a. de c.; mike allen 1331 parque; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5385667
• MDR Text Key: 36741207
• Report Number: 8030665-2016-00029
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022536
• 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: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/01/2018
• Device Catalogue Number: 03-2794-0
• Device Lot Number: 15LR01051
• Other Device ID Number: 00840861100316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2016
• 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: 48 YR
• Patient Weight: 95