MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET ACCESS FLOW REVERSE CON TWISTER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number 03-2794-0

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

A nurse manager at a user facility reported that that there was blood leaking around the blue circle of the bloodline venous sample port immediately after the initiation of a patient's hemodialysis (hd) treatment.The estimated blood loss (ebl) was reported to be 10ml.The treatment was interrupted and the patient was set-up with new supplies.The patient was able to complete treatment with no serious injury or impact.No medical intervention was required.The device was stated to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

The complaint device was returned to the manufacturer for physical evaluation.A visual inspection was performed on the returned bloodline sample and no defects or damages were observed.There were no issues found in the venous injection site.All bonds from the arterial and venous lines were reviewed and found to have been properly assembled.The sample was tested using a 2008t hemodialysis machine for simulated use.During the simulated use test, there were no observations of a leak or air bubbles and no level variations of the venous or arterial drip chambers.There were no observed leaks at the venous injection site.The device worked as intended with no noted abnormalities and no defects identified.The investigation into the cause of the reported problem was not able to confirm the failure mode.The reported injection site blood leak was not able to be duplicated.Therefore, the complaint has been deemed unconfirmed.

Event Description

Follow-up information from the nurse manager revealed that there was blood leaking around the blue circle of the bloodline venous sample port immediately after the initiation of a patient's hemodialysis (hd) treatment.The location of the leak was clarified to have occurred at the blue injection site port on the venous bloodline.

Manufacturer Narrative

Plant investigation: although it was originally stated that the device was available to be returned to the manufacturer for analysis, no sample has been received to date.Therefore, the reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, the dhr review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.

• Brand Name: COMBISET ACCESS FLOW REVERSE CON TWISTER
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7145536
• MDR Text Key: 95924779
• Report Number: 8030665-2017-01160
• Device Sequence Number: 1
• Product Code: KOC
• UDI-Device Identifier: 00840861100316
• UDI-Public: 00840861100316
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 03-2794-0
• Device Lot Number: 17LR01306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2017
• 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