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 03-2742-9

Device Problem Disconnection (1171)

Patient Problems Cardiac Arrest (1762); Blood Loss (2597)

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: 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.

Event Description

A biomedical technician (biomed) at a user facility reported that a patient lost approximately 300 milliliters (ml) of blood during hemodialysis (hd) treatment after the catheter separated from the venous line and fistula needle.This event occurred approximately one hour and forty-five minutes into treatment.It was further stated that the fresenius 2008t hd machine did not alarm.It was reported that the patient coded during hd treatment and was transported to the hospital.The patient did not complete treatment.The facility staff does not believe that the patient code was related to the blood loss and there were no reports from the hospital that supports a relation to the blood loss.The patient was initially admitted to the hospital for observation only, however, the patient experienced a severe and required further treatment.The patient was released from the hospital after three days and has since returned to the facility for regularly scheduled hd treatment.No defect or malfunction of the fresenius products in use during the hd treatment was alleged, observed, or identified prior to, during, or following the event.No samples are available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Clinical investigation: although a temporal association with the adverse events of the patient¿s estimated blood loss and subsequent ¿code¿ and the 2008t machine and custom combi set exist, there is no documentation in the complaint file supporting a causal relationship between the adverse event and any fresenius product.The adverse event of blood loss was a direct result of the patient¿s dialysis venous line being pulled (dislodged) from the cvc port when the patient sneezed during hd treatment leading to the patient subsequently coding which required unknown resuscitation efforts.Additionally, there is no allegation of any machine malfunction.

Manufacturer Narrative

This is follow-up #2 correction: in the initial submission, it stated the following: "the patient was initially admitted to the hospital for observation only, however, the patient experienced a severe and required further treatment." the word "severe" is changed to "seizure.".

Event Description

The patient was initially admitted to the hospital for observation only, however, the patient experienced a seizure and required further treatment.

• 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: 6843700
• MDR Text Key: 85131556
• Report Number: 8030665-2017-00653
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• 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,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 17ER01243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2017
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 71