MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190713

Device Problem Inadequate Ultra Filtration (1656)

Patient Problems Cardiopulmonary Arrest (1765); Loss of consciousness (2418)

Event Date 04/06/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluation: no parts were returned to the manufacturer for physical evaluation.The 2008t hemodialysis (hd) machine was evaluated at the facility by a fresenius regional equipment specialist (res) due to the reported event.The res performed the ultrafiltration (uf) checklist and found a uf balance and uf pump error.Per the res, the uf pump required rebuilding and calibrating or replacement before being placed back in service.The res placed the machine through functional testing as well.The uf pump was rebuilt by the clinic¿s biomed technician and returned to service.A records review was performed on the reported device serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework during the manufacturing process which could be related to the reported event.Additionally, a review of the device history record (dhr) confirmed the results of the in-progress and final quality control (qc) testing met all the requirements.A definitive conclusion regarding the reported incident could not be reached.A supplemental mdr will be submitted upon completion of the investigation. .

Event Description

A user facility reported that patient coded and became unresponsive during their hemodialysis (hd) treatment.It was reported that cardiopulmonary resuscitation (cpr) was performed and the patient was sent to the hospital.There was no blood loss associated with the reported event.The biomedical technician performed an ultrafiltration (uf) problem identification checklist and the machine did not pass.It was reported that the machine, a fresenius 2008t machine, had no alarms during the treatment.A fresenius regional equipment specialist (res) was called on site to perform a machine evaluation.The res technician found a problem with the uf balance and uf pump.The res reported that the uf pump needs to be rebuilt and calibrated or replaced prior to the machine begin returned to service.Per the biomedical technician, the uf pump was rebuilt to resolve the machine issue identified and machine placed back in service.The biomed stated that the patient's event was unrelated to the uf problem found during the machine evaluation.The patient was diagnosed with an av block in the hospital.The patient was treated (details unknown) and discharged.The patient returned to the clinic for their next scheduled hd treatment without issue.Additional information regarding the patient was requested, however, not provided.

Manufacturer Narrative

Additional information: clinical investigation clinical investigation: it was reported a male patient (pt) became unresponsive and suffered cardiopulmonary arrest during an outpatient hemodialysis (hd) treatment.It was reported the machine did not alarm and the pt did not experience nay blood loss during hd treatment.Further details surrounding the pt¿s hd treatment leading up to the pt¿s cardiopulmonary arrest are unknown.Reportedly, the pt received cardiopulmonary resuscitation (cpr) in the outpatient clinic (details unknown) and the pt was subsequently transported to the hospital for further medical management.Per the biomedical technician, the pt was diagnosed with an atrioventricular (av) block while hospitalized.Further details surrounding the pt¿s hospitalization and treatment are unknown.It was reported the pt was discharged from the hospital (unknown date) and resumed regularly scheduled hd treatment in the outpatient hd clinic without further reported issues.The machine was sequestered after the event and the biomedical technician reportedly performed a uf problem identification check and the machine did not pass evaluation.There is a temporal relationship between the hd treatment with and the pt¿s loss of consciousness and cardiopulmonary arrest that led to inpatient hospitalization.It was reported the pt¿s cardiopulmonary arrest was associated with an av block in the pt¿s heart (reportedly diagnosed in the hospital).However, post incident evaluation of the machine indicated the machine failed uf verification testing with the uf pump and uf balance.The machine has not been returned to the manufacturer for further failure analysis; therefore, it is unknown why the machine reportedly did not alarm during the pt¿s hd treatment.Due to the possibility of inaccurate fluid removal with identified uf balancing and uf pump failure; the machine cannot be excluded as a possible causal or contributory factor in the pt¿s cardiopulmonary arrest event.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• 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: 7467331
• MDR Text Key: 106697495
• Report Number: 2937457-2018-01169
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 05/04/2018
• Supplement Dates FDA Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2013
• 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; Life Threatening; Required Intervention