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

Catalog Number 03-2622-3

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

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

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility biomedical technician (biomed) reported that during a patient¿s hemodialysis (hd) treatment, there was a blood leak at the luer lock connection from the venous section of the fresenius bloodline to the level detector on the fresenius 2008t hd machine.There was blood on the front of the machine from the blood leak but the transducer protector to the level detector had no evidence of blood and was dry.Follow-up information from the facility nurse revealed that the blood leak occurred approximately thirty minutes after the initiation of the patient¿s treatment.There was no machine alarm.The nurse stated the staff tightened the bloodlines connection at the transducer section of the bloodline and it was suspected that the blood leak was from a loose connection from the bloodlines into the transducer protector.There was no observed defect or damage to the bloodline.The total estimated blood loss (ebl) was noted as being possibly 100 milliliters (ml).After the connection was tightened, the patient continued with treatment on the machine.No patient injury or adverse effects 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.Following the completion of the patient¿s treatment, the machine was removed from service for evaluation.A fresenius regional equipment specialist (res) performed an on-site evaluation of the machine.The res inspected the machine and found no blood at the venous luer lock connection.The res verified that the machine was operating properly.The unit was returned to service at the user facility without a recurrence of the event as reported.No machine parts are available to be returned to the manufacturer for evaluation.The bloodline device was not available to be returned to the manufacturer for evaluation as it was discarded by the facility.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer and the lot number was not provided.Therefore, the complaint cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A manufacturing review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius bloodlines under catalog number 03-2622-3 shipped to this account within the selected time frame.A records review was performed on all eight lots identified.An investigation of the device history record (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 lots met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.

• Brand Name: 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: 6741241
• MDR Text Key: 80952968
• Report Number: 8030665-2017-00466
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100231
• UDI-Public: 00840861100231
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2622-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: FRESENIUS 2008T HEMODIALYSIS MACHINE