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 Air Leak (1008)

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

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: although it was initially stated that the device was available to be returned to the manufacturer for evaluation, no parts have been received by the manufacturer as of this time.Therefore, the reported complaint is not confirmed.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.

Event Description

An area technical operations manager (atom) for a user facility reported that there was visible air in the patient¿s blood pump segment of the bloodlines approximately 30 to 60 minutes after the initiation of a patient¿s hemodialysis (hd) treatment while using a fresenius 2008t hd machine.The machine did not alarm as the air was noticed prior to the air detector module and occlusion clamp.The priming technique was reported to be performed correctly.There was no patient injury or adverse reaction reported and no medical intervention was required.It was not stated that the patient¿s blood was returned; nor was it stated that there was no blood loss.However, it was stated that after the nurse evaluated the patient following the event, the patient was able to complete treatment without further issue.Following the event, the machine was removed from service for evaluation.The atom recalibrated the air detector and performed a rotor occlusion pressure test on the machine.The test results were below the expected range.A fresenius regional equipment specialist (res) performed on-site service.The res attempted to verify the rotor occlusion test, but the blood pump rotor failed, achieving no more than 15-17 psi.The res advised the atmo to replace the rotor or arterial blood pump module, stating that the minimum 25 psi could be achieved by ensuring the water was warmed above 37°c.The res did not make any repairs and completed the machine functional checks.No defect or damage was reported with the dialyzer, bloodlines, or packaging.There were no external leaks noted.The bloodlines were stated to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Device evaluation: the device was returned to the manufacturer for physical evaluation.A visual examination of the returned device did not identify any defects.The returned device 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 variation of the venous or arterial drip chambers was visible to indicate the introduction of air into the blood circuit.The device worked as intended with no noted abnormalities noted.The investigation into the cause of the reported problem was not able to confirm the failure mode.The reported defect of air being in the lines was not able to be duplicated.The testing of the returned sample could not reveal a probable cause for the customer complaint.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: 7128859
• MDR Text Key: 95810732
• Report Number: 8030665-2017-01118
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 17KR01196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2017
• 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
• Patient Age: 64 YR
• Patient Weight: 68