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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008, NO HEPARIN LINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008, NO HEPARIN LINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
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.
 
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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 Key5537620
MDR Text Key41531243
Report Number8030665-2016-00157
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962081
Number of Events Reported1
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 Number03-2742-9
Other Device ID Number00840861100309
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/01/2016
Initial Date FDA Received03/31/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/09/2016
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 Number1
Patient Outcome(s) Death;
Patient Age74 YR
Patient Weight77
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