MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008, NO HEPARIN LINE; 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 Problems Cardiac Arrest (1762); Death (1802)

Event Date 02/26/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).No parts were returned to the manufacturer for physical evaluation and the plant investigation is on-going.Post market surveillance has commenced a clinical investigation.A supplemental medwatch report will be submitted upon completion of these investigations.

Event Description

A user facility reported a patient death during an acute hemodialysis treatment.Per event follow up with clinic manager, this patient was not a dialysis patient and was receiving emergency hemodialysis due to acute kidney failure.The patient's dialysate flow rate was 300 ml with a blood flow rate of 250 ml.The patient had a temporary catheterization placed a day prior to this event occurring.The clinic manager alleged the patient had received a retro peritoneal tear due to the temporary catheterization, which led to internal bleeding.Additional blood was ordered and the doctor prescribed plavix.Hemodialysis commenced and a blood transfusion was initiated about 1.5 hours into treatment.At this point in time, the patient was reported unresponsive.The blood was rinsed back and cardiopulmonary resuscitation (cpr) was initiated by emergency response personnel.No external blood leak was observed.The patient was unable to be resuscitated and expired.The hemodialysis machine was pulled for evaluation and the facility's biomedical technician confirmed failure of functional testing in regards to negative stabilization pressure.The deaeration pressure was calibrated to resolve the issue.No alarms or machine malfunctions reported during treatment.The unit remains at the user facility.The dialyzer and bloodline are not available for evaluation by the manufacturer as both were discarded by the user facility.

Manufacturer Narrative

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 blood lines shipped to this account within the selected time frame.A records review was performed on the 11 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 march 4, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.There is no documentation in the medical record supporting a possible association between the fresenius dialysis products and the event of outcome of death.According to the received medical records, the cause of death was due to severe coronary artery disease, retroperitoneal hematoma, and acute renal failure.

• Brand Name: FRESENIUS COMBISET 2008, NO HEPARIN LINE
• 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: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5537620
• MDR Text Key: 41531243
• Report Number: 8030665-2016-00157
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/09/2016

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?: 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
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2016
• 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): Death
• Patient Age: 74 YR
• Patient Weight: 77