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 Problems Disconnection (1171); Fluid/Blood Leak (1250); No Fail-Safe Mechanism (2990)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Dyspnea (1816); Exsanguination (1841); Confusion/ Disorientation (2553); Blood Loss (2597)

Event Date 10/27/2018

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal relationship exists between hd therapy utilizing the custom combi set and patient connector clip (hemaclip) and the patient¿s adverse event(s) of difficulty breathing, pale pallor, blood loss, loss of consciousness and subsequent expiration.The cause of the event(s) was a direct result of the patient¿s dialysis venous bloodline separating from the arterial lumen of the catheter.The cause of the actual disconnection however is unknown; therefore, causality cannot be determined.Catheter/bloodline separation is uncommon; however, these event(s) can result in serious injury, significant blood loss and even death.Access lines should always remain visible to enable the detection of possible blood leaks.Based on the information available, the custom combi set and patient connector clip (hemaclip) cannot be disassociated from the event.There is no documentation of any defect(s) at the connection site, and samples were not retained following the event(s).Therefore, no manufacturer investigation/evaluation can be made of the suspect product(s).Additionally, it is unknown if the hemaclip was engaged prior to the reversal of the bloodlines.If there is any interruption during hd therapy, it is imperative the hemaclip be reapplied/reexamined for proper connection if manipulated in any way.

Event Description

A user facility clinical manager (cm) reported that a patient expired following hemodialysis (hd) treatment.Seventeen minutes after the initiation of the patient¿s hemodialysis (hd) treatment, it was discovered that the prescribed blood flow rate (bfr) could not be achieved.Staff reversed the patient¿s bloodlines in an effort to improve the patient¿s bfr, and a hemaclip was applied to the arterial lumen and venous bloodline of the patient¿s hd catheter; the treatment was restarted.At approximately 15:30, the patient was observed having difficulty breathing and was visibly pale, and blood was noted on the right finger.The patient¿s catheter ports were clamped and a saline bolus was administered.Pablo confirmed that emergency medical services (ems) were called and cardiopulmonary resuscitative (cpr) was initiated.The patient expired in the emergency room at approximately 16:16.Additional information regarding the patient and the event was requested, however, not provided by the facility.The patient connector clip and bloodlines were reported to have been discarded and are not available for manufacturer evaluation.

Manufacturer Narrative

Correction: plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the user facility for the ten (10) month time frame which immediately preceded the event occurrence date, however no information was found.An investigation of the device history records (dhr) could not be conducted because the lot number is unknown and no information was found in the shipping records.The instructions for use were reviewed and it was confirmed that the connection and disconnection steps were explained in a detailed manner, including pictures and visual aids.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.

• 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: 8103446
• MDR Text Key: 128327042
• Report Number: 8030665-2018-01869
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/07/2018,12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2742-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2018
• Distributor Facility Aware Date: 10/27/2018
• Device Age: 1 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/08/2018
• Date Manufacturer Received: 12/21/2018
• 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 DIALYZER; FRESENIUS GRANUFLO DIALYSIS CONCENTRATE; FRESENIUS HEMACLIP; FRESENIUS NATURALYTE DIALYSIS CONCENTRATE
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 44