MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2722-9

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: although it was initially stated that the complaint device was available to be returned to the manufacturer for physical evaluation, no sample has been received by the manufacturer for evaluation to date.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.The reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation.

Event Description

A user facility nurse manager reported that during a patient¿s hemodialysis (hd) treatment, approximately 2.5ml (milliliters) of blood leaked from the connection of the arterial portion of the fresenius bloodline which attaches to the catheter.This occurred approximately one hour twenty minutes after initiation of the patient¿s treatment.The hd machine did not alarm as there was no disruption in arterial pressure.It was reported that when the bloodline was removed from the catheter, there was a small crack visible in the bloodline.The treatment was interrupted, and the patient was set up with new supplies.The patient was given prophylactic antibiotic (vancomycin) medication and the results of the patient¿s hemoglobin remained unchanged from the blood loss.No patient adverse effects or injuries were experienced, and no medical intervention was required.The patient was able to complete treatment on the hd machine without any further interruptions or complications.The bloodline device was stated to be available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information: device evaluation: the device was returned to the manufacturer for physical evaluation.The sample was received with a non-fresenius medical care north america (fmcna) connector attached to the venous and arterial patient end connector.A visual examination of the returned device found that the arterial patient end connector was within acceptable specifications for luer lock connectors and there were no observed cracks or defects, such as collar or taper damage.The male conical fitting of the arterial patient connector was dimensionally inspected using ansi male gauge iso 594/1 1986 (e), and the sample was found within the acceptable range.The visual inspection of the entire returned bloodline sample did not find any damage or irregularities.The sample was tested using a 2008t hemodialysis machine for simulated use.During the simulated use test, there were no observations of a leak, disconnection, air bubbles, and no level variation of the venous or arterial drip chambers or of any alarm.The device worked as intended with no noted abnormalities.The investigation into the cause of the reported problem was not able to confirm the reported leak.The testing of the returned sample could not reveal a probable cause for the customer complaint as the reported leak was not able to be duplicated.Therefore, the complaint is not confirmed.

• Brand Name: CUSTOM COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• 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: 7142387
• MDR Text Key: 95746761
• Report Number: 8030665-2017-01151
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 17HR01024
• 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: 06/02/2017
• 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