MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500318E

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) 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) 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) 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 complainant did not provide a dialyzer sample for evaluation.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.There was no dialyzer lot number provided for the event.As such, an sap search was performed to obtain all lot numbers with the reported catalog number (0500318e) delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.The production record for each lot identified on the sap search of the delivered product to the customer was reviewed.There was no indication during the review of the batch records of product non-acceptance or deviation in the manufacturing process potentially related to the complaint.This includes non-conformance, rework, labeling, process controls, and any other occurrence in production.Due to the nature of the complaint, other disposable and durable complaints were opened aside from the dialyzer investigation.These other complaints are assigned to their respective manufacturing sites (outside of (b)(4)).The conclusion of the dialyzer investigation is that there is no indication that the dialyzer did not meet release criteria or manufacturing specifications.Information received indicated that the dialyzer clotted due to the hose/machine leak issue and not due to a defective dialyzer.

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) 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) 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

Plant investigation: the complainant did not provide a dialyzer sample for evaluation.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.There was no dialyzer lot number provided for the event.As such, an sap search was performed to obtain all lot numbers with the reported catalog number (0500318e) delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.The production record for each lot identified on the sap search of the delivered product to the customer was reviewed.There was no indication during the review of the batch records of product non-acceptance or deviation in the manufacturing process potentially related to the complaint.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production.Due to the nature of the complaint, other disposable and durable complaints were opened aside from the dialyzer investigation.These other complaints are assigned to their respective manufacturing sites (outside of ogden).The conclusion of the dialyzer investigation is that there is no indication that the dialyzer did not meet release criteria or manufacturing specifications.Information received indicated that the dialyzer clotted due to the hose/machine leak issue and not due to a defective dialyzer.

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 121 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 125.6 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: OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7062471
• MDR Text Key: 93596876
• Report Number: 1713747-2017-00374
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002761
• 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,Followup
• Report Date: 02/26/2018

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: 0500318E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/19/2018
• 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): Required Intervention
• Patient Age: 61 YR