MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2742-9

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 06/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted as part of a system level review which will include an investigation of all fresenius products being used at the time of the event.Manufacturing investigation: the device was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A manufacturing review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius bloodlines from the reported catalog number (03-2742-9) shipped to this account within the selected time frame.A records review was performed on all lots identified.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lots passed all release criteria.A review of the batch production records did not reveal a probable cause for the customer complaint.There were no non-conformances identified that relate to the reported event, and all lots met release criteria.Clinical investigation: the patient medical records were provided by the facility on (b)(6) 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.Based on the 19 pages of medical records information, it appears that this (b)(6) old male chronic kidney disease patient on intermittent hemodialysis (hd) therapy being carried out via fresenius dialysis products, started hd therapy on (b)(6) 2016.On (b)(6) 2016, the patient climbed a ladder at home to change a light bulb, experienced a fall from approximately four feet onto the handlebars of an all-terrain vehicle.The patient incurred multiple abrasions to the right, mid, and lower chest wall, and presented to a hospital¿s emergency department with significant (10 of 10) rib pain with a ¿popping¿ sensation to right ribs with movement and breathing that was not relieved by anything.The patient was diagnosed with multiple closed rib fractures, pulmonary contusion, a small hemopneumothorax, and was admitted for observation and pain control.During the admission on (b)(6) 2016, the patient was initiated on calcium gluconate, kayexalate, insulin and glucose (dose, routes, and frequencies not reported) to address the hyperkalemia.On (b)(6) 2016, the patient experienced an episode of pulseless electrical activity (pea) approximately 11 minutes after treatment initiation and required cardiopulmonary resuscitation (cpr) and administration of sodium bicarbonate and epinephrine.The patient was revived.There is no documentation in the medical record supporting a possible association between the fresenius dialysis products and the event of cardiopulmonary arrest.However, there is a probable association between the patient¿s co-morbid diseases of myocardial infarction, chronic obstructive pulmonary disease, cabg, the event of a hemopneumothorax, and the event of cardiopulmonary arrest.

Event Description

During a request for information due to a patient adverse event, a facility biomedical technician reported the same patient had "coded before" during hemodialysis and was now "okay." no further information was provided.A second attempt to retrieve additional information was performed by contacting the charge nurse (cn) at the facility.The cn provided medical records (mr) and the hd treatment sheets.This case involved a male patient who was hospitalized on (b)(6) 2016 with a primary complaint of right lower chest pain that resulted from a fall sustained at home.The patient's admission diagnosis was fractured ribs and a small right hemopneumothorax.Furthermore, the patient had elevated potassium levels of 6.0 upon admission so the decision was made to start the patient on hemodialysis (hd).The cn reported the patient was ckd ¿stage 4 or 5¿ upon admission with no history of previous dialysis reported.The patient received an unknown number of hemodialysis treatments between (b)(6) 2016 without issue.On (b)(6) 2016, within seven (7) minutes of the hd treatment being initiated, the patient experienced a loss of consciousness and had a pulseless electrical activity (pea) episode which required that cardiopulmonary resuscitation (cpr) be performed.Following the successful resuscitation on (b)(6) 2016, the patient was transferred from the dialysis unit to the intensive care unit (icu).The patient's relevant medical history included chronic obstructive pulmonary disease (copd), hypertension, diabetes mellitus type 2, chronic kidney disease, and hyperlipidemia with coronary artery bypass graft on an unknown date.Relevant concomitant medications were not provided for this event date.Hd orders from (b)(6) 2016 revealed a treatment time of 3 hours, blood flow rate of 400ml/min, dialysate flow rate of 800ml/min, dialyzer type f160nr, ultrafiltration (uf) goal of 1000ml, potassium 3, calcium 2.5, bicarbonate 38, sodium 138, and access type right non-tunneled internal jugular catheter.Machine safety checks from (b)(6) 2016 showed that the unit passed alarm tests, normal venous limits enabled, total chlorine log was completed, machine log was completed, reverse osmosis machine log completed, machine temperature 35.0 degrees celsius, machine conductivity 14.0, meter conductivity 14.0, ph 7.4, extracorporeal circuit connections secured, saline line double clamped, and hemo-safe was applied.Pre-treatment assessment from (b)(6) 2016 revealed lung sounds clear to auscultation bilaterally, the patient was intubated with an oxygen rate of 40%, and level of consciousness was sedated.The patient¿s treatment was initiated at 12:54 pm.At 1:05 pm, the patient became unresponsive with pulseless electrical activity (pea).Cardiopulmonary resuscitation (cpr) efforts were initiated, and the patient was administered epinephrine 1mg, calcium chloride 1 ampule, and sodium bicarbonate 1 ampule via intravenous route.An attempt was made to return the blood within the extracorporeal circuit.However, only 100ml of blood was able to be returned.The patient¿s estimated blood loss was noted as being approximately 200ml.The treatment was discontinued and the patient was disconnected from the hd machine.The return of spontaneous circulation occurred; therefore, cardiopulmonary resuscitation efforts were discontinued.The ultrafiltration goal from the treatment on (b)(6) 2016 was net positive 300ml.No device malfunctions were alleged, observed or reported during the brief treatment.The machine passed all pre-treatment testing.The machine was removed from service after this event and evaluated by the facility biomedical technician (bmt).No machine malfunctions were alleged, observed, or identified and the unit was returned to service at the user facility without issue.The user facility reported that the patient used a different hd machine during this treatment, but had a similar outcome as the event experienced during the hd treatment performed on (b)(6) 2016.All hd treatments that followed this incident were noted as being uneventful, with no recurrence of any patient adverse events that had been previously observed.The patient continued to be dialyzed using the same type of fresenius dialyzer and bloodline product until their discharge on (b)(6) 2016 with no further issues being reported.No malfunction of any fresenius product in use during the hd treatment performed on (b)(6) 2016 was alleged, observed, or identified prior to, during, or following the event.The patient was discharged from the hospital on (b)(6) 2016 and is scheduled to begin chronic outpatient hemodialysis.The patient¿s current condition was noted as being ¿well.¿ the 2008k2 hemodialysis (hd) machine is not available for evaluation.The dialyzer and bloodline are not available for evaluation by the manufacturer as both were discarded by the user facility.No samples of the acid/bicarb in use during the treatment are available for analysis.

• Brand Name: CUSTOM COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5855117
• MDR Text Key: 51455609
• Report Number: 8030665-2016-00400
• Device Sequence Number: 1
• Product Code: FJK
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2742-9
• Other Device ID Number: 00840861100309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2016
• 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; Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 70