MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 03-2742-9

Device Problems Partial Blockage (1065); Fluid/Blood Leak (1250); Cut In Material (2454)

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pain (1994); Cramp(s) (2193); Blood Loss (2597)

Event Date 08/05/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

On (b)(6) 2017, this patient on renal replacement therapy (rrt) was receiving hemodialysis (hd) treatment via a 2008t machine (using fresenius combi-set bloodline and optiflux 180nre dialyzer) with a pre-treatment weight noted at (b)(6) kilograms (kg) and an ultrafiltration goal programmed for 1600 milliliters(ml).Approximately, one hour into hd treatment the patient reported feeling ¿funny¿ with complaints of nausea, cramping (in both lower extremities) and became hypotensive (systolic blood pressure (bp) reading in the 90¿s millimeter of mercury (mm/hg).Concomitantly, it was discovered the arterial hansen hose in the back of the 2008 t machine was ¿cut¿ by the base clamp (reportedly coming from the factory overtightened) and leaking in the rear of the machine.At the same time, the 2008t machine reportedly alarmed high transmembrane pressure (tmp) and patient¿s extracorporeal circuit was observed to be clotted.As a result, the patient was not able to be reinfused his blood in the extracorporeal circuit and the patient lost approximately 200 cubic centimeters (cc) of blood.Furthermore, it was alleged the 2008 t machine removed 4 kg¿s from the patient (in one hour of hd treatment) and the patient¿s weight was approximately (b)(6) kg¿s when symptoms began.The patient¿s head was lowered and the patient was administered a total of 600 ml of normal saline (in two 300 ml bolus doses).The patient¿s systolic bp improved to 120 mm/hg).The patient¿s treatment was ended (unknown if all of pt.Blood in circuit returned) and the patient was bp was stabilized (unknown blood pressure) and cramping resolved (after approximately one hour).The patient¿s post weight was reportedly (b)(6) kg and the patient was discharged home.However, later that night the patient reported experiencing leg pain.It was reported the patient did not experience the leg pain prior to the incident and the patient underwent magnetic resonance imagining (mri) on an unknown date (unknown results).Observation of the 2008 t machine (after the incident) indicated that the machine reading indicated a total of 449 ml was removed during the patient¿s treatment.Subsequently, the machine was pulled from service pending further investigation.It was reported the hansen hose was repaired to allow for disinfection of the machine pending investigation.

Manufacturer Narrative

Occupation: health care professional.Plant investigation: the device was not returned to the manufacturer for physical evaluation, and the lot number was not able to be obtained to date.Distribution records were reviewed to identify potential lots of this product shipped to the customer over the past 3 months.The entire set of lots have been sold and distributed.Batch records for the lots identified were reviewed and confirmed there were no deviations or nonconformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

Event Description

On (b)(6) 2017, this patient on renal replacement therapy (rrt) was receiving hemodialysis (hd) treatment via a 2008t machine (using fresenius combi-set bloodline and optiflux 180nre dialyzer) with a pre-treatment weight noted at 125.1 kilograms (kg) and an ultrafiltration goal programmed for 1600 milliliters(ml).Approximately, one hour into hd treatment the patient reported feeling ¿funny¿ with complaints of nausea, cramping (in both lower extremities) and became hypotensive (systolic blood pressure (bp) reading in the 90¿s millimeter of mercury (mm/hg).Concomitantly, it was discovered the arterial hansen hose in the back of the 2008 t machine was ¿cut¿ by the base clamp (reportedly coming from the factory overtightened) and leaking in the rear of the machine.At the same time, the 2008t machine reportedly alarmed high transmembrane pressure (tmp) and patient¿s extracorporeal circuit was observed to be clotted.As a result, the patient was not able to be reinfused his blood in the extracorporeal circuit and the patient lost approximately 200 cubic centimeters (cc) of blood.Furthermore, it was alleged the 2008 t machine removed 4 kg¿s from the patient (in one hour of hd treatment) and the patient¿s weight was approximately (b)(6) kg¿s when symptoms began.The patient¿s head was lowered and the patient was administered a total of 600 ml of normal saline (in two 300 ml bolus doses).The patient¿s systolic bp improved to 120 mm/hg).The patient¿s treatment was ended (unknown if all of pt.Blood in circuit returned) and the patient was bp was stabilized (unknown blood pressure) and cramping resolved (after approximately one hour).The patient¿s post weight was reportedly (b)(6) kg and the patient was discharged home.However, later that night the patient reported experiencing leg pain.It was reported the patient did not experience the leg pain prior to the incident and the patient underwent magnetic resonance imagining (mri) on an unknown date (unknown results).Observation of the 2008 t machine (after the incident) indicated that the machine reading indicated a total of 449 ml was removed during the patient¿s treatment.Subsequently, the machine was pulled from service pending further investigation.It was reported the hansen hose was repaired to allow for disinfection of the machine pending investigation.

• Brand Name: CUSTOM COMBI SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• 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: 7062472
• MDR Text Key: 93585451
• Report Number: 8030665-2017-01036
• Device Sequence Number: 1
• Product Code: KDI
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• 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
• Device Age: MO
• Date Manufacturer Received: 12/18/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR