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

Model Number 03-2722-9

Device Problems Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423)

Patient Problems Cardiac Arrest (1762); Death (1802); Pain (1994)

Event Date 10/10/2020

Event Type  Death  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy utilizing the combi set true flow bloodlines and the patient¿s unresponsiveness requiring cpr leading to the patient¿s subsequent expiration.The etiology of these events remains unknown; therefore, causality cannot be established.Presently there is no objective evidence indicating a fresenius device or product deficiency caused or contributed to the patient¿s expiration.At the time of this report, there has been no report or receipt of a primary and/or secondary cause of death, esrd death notification, death certificate, autopsy report and no documentation detailing the evaluation of the suspect device.The combi set true flow bloodlines cannot be excluded from having a possible causal or contributory role in the patient¿s expiration, as there is insufficient evidence to conclude the root cause of these events.However, it is well-known the esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population.Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the combi set bloodlines shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

Event Description

Fresenius was made aware of a medwatch report submitted from an outpatient hemodialysis (hd) user facility that stated a patient utilizing the combi set true flow bloodlines became unresponsive and required cardiopulmonary resuscitation (cpr).There was no specific allegation that the event was due to a deficiency or malfunction of any fresenius product(s) or device(s).Prior to their regularly scheduled dialysis treatment, the patient's vital signs were taken.The patient¿s vitals presented a blood pressure of 166/66, pulse of 88/min and a temperature of 98.5 f.One hour and nine minutes into the patient¿s dialysis treatment the bloodlines were noted to be clotting.The hd treatment was discontinued, and the patient¿s fistula needles were disconnected from the venous and arterial lines of the combi set.Both patient¿s fistula needles were flushed and remained in the patient.A new dialysis system (including combi set true flow lines and an optiflux f180nre dialyzer) were to be set up and primed.Upon the restart of the patient¿s dialysis treatment, the venous line was reconnected to the venous needle and the arterial line was reconnected to the arterial needle.Within approximately two minutes, the patient reported pain at the venous needle site and became unresponsive.Cpr was initiated and emergency services were activated.Emergency services arrived, assumed cpr and transferred the patient to the hospital.Following the event, inspection of the venous line and dialyzer presented air in the lines and no visible saline.The arterial line was noted to have visible saline.It was reported that the patient expired, and the cause of death was not provided.It was reported in the medwatch form that the combi set true flow bloodlines were available to be returned for a manufacturer evaluation.Subsequent attempts to obtain additional information (e.G.Demographics, medical history, end-stage renal disease [esrd] death notification, discharge summary, autopsy report, device and product evaluation documentation and/or death certificate) have proven unsuccessful.To date no further information has been provided by the user facility despite multiple attempts made.

• 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.; director, quality systems; 1100 e, military hwy, suite c; pharr TX 78577
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 10840701
• MDR Text Key: 216312104
• Report Number: 8030665-2020-01674
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03-2722-9
• Device Catalogue Number: 03-2722-9
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 10/23/2020
• 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
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 99