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 CUSTOM COMBI SET

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problems Anemia (1706); Hyperthermia (1909); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

A temporal association with the adverse events of the patient¿s blood loss and hospitalization and the fresenius blood lines and hemaclip exist.However, there is no documentation of any defects at the connection site of the venous blood line to the catheter or any other venous blood line issues leading up to the event that would cause the loose connection.It is unknown what may have occurred to cause the catheter and venous blood line to become unsecure an hour and a half after the initiation of hd therapy.There is no documentation to state if the patient access site was uncovered.Reportedly, a hemaclips was placed on the venous line, but it is unknown what make of catheter was utilized and if it was compatible with the hemaclips.The adverse event was a direct result of the patient¿s dialysis venous line becoming unsecure and leading to the blood loss, and hospitalization.A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

Obtained from a voluntary medwatch (b)(4): on (b)(6) 2017 approximately an hour and a half into a scheduled dialysis treatment, the 2008t machine alarmed to alert the operator of a low blood pressure (bp) 55/21.The patient was found unresponsive, placed in the trendelenburg position and approximately 150-200 ml of blood was noted on the patient¿s clothing and chair.The venous combi set line connection to the venous portion of the right jugular catheter was observed loosened with the hemaclip device intact.It is not known why the connection was loose.Per the hd nurse, the patient did not tug on the lines and the set up was completed properly per the clinic checklist.The connection was re-secured, normal saline (unknown volume) was administered and 911 was called.After saline administration the patient¿s bp increased 64/31 and the patient was alert and responded verbally.The patient was transferred to the hospital via emergency medical services (ems).Additional information was solicited.Patient medical records indicated that the patient presented to the emergency room (er) with reported hypotension and blood loss with a change in mental status.Systolic blood pressures were reported in the 40s per ems and two liters of intravenous (iv) fluid by dialysis and one liter en route to the er were administered.There was no active bleeding upon arrival.Hemoglobin (hgb) and hematocrit (hct) were obtained and showed hgb 7.8 and hct 25.9%.The patient was admitted for further workup and care and transfusion of blood.Prior to the dialysis treatment the patient stated she was not feeling right and had shortness of breath, was tired and had a headache and right shoulder pain.The shoulder pain was related to severe osteoarthritis which was seen on imaging.The patient was diagnosed with hypotension, altered mental status and hypothermia (temperature 95.8 f) all secondary to blood loss during dialysis.The patient was transfused with two units of packed red blood cells and the headache was treated with fioricet.The hypotension resolved.The patient¿s pro brain-type natriuretic peptide (probnp) showed 17,200 which the physician stated was likely secondary to the patient¿s end stage renal disease (esrd) and not related to any heart failure.It is unknown if the patient continued hd treatments while hospitalized.The patient was discharged in stable condition on (b)(6) 2017.Device sample was requested.

Manufacturer Narrative

The alleged event was not confirmed by the manufacturing plant.The alleged device was received by the manufacturing plant without original package from the customer.During the evaluation the alleged failure stated in the complaint was not confirmed.The male conical fitting of the venous patient connector was dimensionally inspected using ansi male gauge was found acceptable.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

Event Description

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• 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: 7147945
• MDR Text Key: 96223174
• Report Number: 8030665-2017-01170
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CUSTOM COMBI SET
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 17KR01152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Device Age: MO
• Date Manufacturer Received: 01/19/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 95 YR
• Patient Weight: 50