MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP; HEMODIALYSIS SYSTEM FOR HOME USE

Model Number 2008K@HOME

Device Problem Pressure Problem (3012)

Patient Problems Loss of consciousness (2418); Blood Loss (2597)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon the completion of this activity.

Event Description

A technologist reported that per a hospital personal support worker (psw), a home hemodialysis (hd) patient encountered transmembrane pressure (tmp) alarms on the fresenius 2008k@home hd machine approximately 8-10 minutes after initiation of the hd treatment.The patient's blood pressure was 150/70 prior to the start of hd treatment.The blood pump was set to 300 ml/min.It was reported that the home hd patient passed out while connected to the machine.The patient's blood in the arterial side of the blood line appeared normal in color; however, the blood in the venous side of the blood line was a burgundy color.The patient lost a circuit of blood and was sent to the hospital.It was reported that the patient has fully recovered with no ill effects.Following the event, a fresenius medical care (b)(4) technician performed machine evaluation.The chlorine was checked at the carbon tanks and sample port of the hd machine and the results passed.In service mode, all tests passed for the blood pump, arterial pressure leakage, venous pressure leakage, level detector, conductivity, temperature, and diasafe filter.The technician checked the ultrafiltration (uf) pump and found the value at 23.6 cc.The technician calibrated the uf pump to 24.0 cc.The tmp was also found out of calibration at 0 mmhg tmp 50 and venous 1, and also at -250 mmhg tmp 199 and venous 1.After the technician did calibration, the value was in the required range.The electrical safety test was performed and the machine was put in heat disinfect mode.The technician found a loose pin on the blood pump rotor and replaced it.

Manufacturer Narrative

Clinical investigation: although a temporal association between the patient¿s loss of consciousness and the home hemo dialysis (hhd) treatment with the fresenius 2008k at home hd machine exists, there is no documentation to support a causal relationship between the adverse event of the patient losing consciousness and subsequent need for an emergency room (er) evaluation and the 2008k at home hd machine.Furthermore, there is no documentation that the patient required or received any medical intervention as a result of the adverse event.

Event Description

The patient was having hemodialysis (hd) treatment at home when the fresenius 2008k at home hd machine was giving high transmembrane pressure (tmp) alarms.The patient was found unconscious by the personal support worker (psw) and the patient¿s wife a few minutes after the machine was giving high tmp alarms.The patient lost a circuit of blood as the psw was instructed to not return the patient¿s blood.The estimated blood loss was reportedly 300ml.The patient was sent to the emergency room (er) hospital via ambulance for evaluation.In the er, the patient had a computerized tomography (ct) of the head, chest x-ray, and blood work.The patient received medications for high blood pressure and was later dialyzed at the in-center facility.The patient was discharged to home the same day with instructions to complete cardiac follow-up.The patient is continuing with hd therapy without any further problem.Following the event, a fresenius medical care canada technician performed machine evaluation.The technician reported that the tmp was found out of calibration and was a possible dialysate pressure transducer calibration issue.The technician performed tmp calibration and returned the machine to service after all functional checks had passed.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.The 2008k at home hemodialysis (hd) machine was evaluated by a fresenius medical care canada (fmcc) technician.The technician checked the ultrafiltration (uf) pump and found the value at 23.6cc.The technician calibrated the uf pump to 24.0cc.The tmp was also found out of calibration at 0 mmhg tmp 50 and venous 1, and also at -250mmhg tmp 199 and venous 1.After the technician performed tmp calibration, the value was in the required range.The technician returned the machine to service after all functional checks had passed.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was able to confirm the failure mode.The fmcc technician identified that the uf pump and tmp was out of calibration.Therefore, the complaint has been deemed confirmed.

• Brand Name: 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP
• Type of Device: HEMODIALYSIS SYSTEM FOR HOME USE
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7145471
• MDR Text Key: 95726734
• Report Number: 2937457-2017-01413
• Device Sequence Number: 1
• Product Code: ONW
• UDI-Device Identifier: 00840861100958
• UDI-Public: 00840861100958
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2008K@HOME
• Device Catalogue Number: 190395
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 66