MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FRESENIUS COMBISET BLOODLINES

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

Patient Problems Arrhythmia (1721); Aspiration/Inhalation (1725); Cardiac Arrest (1762); Death (1802); Renal Disease, End Stage (2039)

Event Date 05/06/2011

Event Type  Death  

Event Description

The plaintiff's attorney alleged the pt experienced aspiration pneumonitis complications, cardiac arrest and subsequently expired alleged to have been caused by the product administered for dialysis treatment.The pt was dialyzed for 3 1/2 hours on a 2 potassium bath the day of her demise.Potassium in the morning was 6.0, phosphorus 3.4, calcium 8.7 with a hemoglobin of 9.The pt complained of left upper quadrant pain the prior day.A scan of the abdomen and pelvis with oral (no intravenous) contrast was essentially unrevealing.The pt maintained on telemetry without evidence of arrhythmia until and asystole episode after returning from dialysis.Blood pressure at conclusion of dialysis was 134/76.Approximately 15 minutes after arriving back to the floor, the pt was sitting, preparing to take a shower with assistance from the nurse and subsequently had a witnessed syncopal episode with no fall or hit to the head.Initial rhythm was asystole, which after administration of epinephrine was pulseless electrical alternans.Resuscitation was administered for 29 minutes with securing of airways as well as intravenous access; however, a pulse was never returned.The certificate of death shows cause of death as end stage renal disease and aspiration pneumonitis.

Manufacturer Narrative

Additional info (death certificate and discharge summary) was received and a clinical investigation was completed accordingly.The pt experienced aspiration pneumonitis complications, cardiac arrest and subsequently expired which is alleged by the plaintiff's attorney to have been caused by the product administered for dialysis treatment.The pt was hospitalized several days after an anaphylactic reaction in which appeared to be a cephalosporin after having presented to the hospital with access pain.The pt had pulseless electrical activity arrest and had cardiopulmonary resuscitation administered.The pt left the hospital against medical advice.However, the pt returned to the hospital next day which was approximately six days prior to her demise.The pt was on bipap with evidence of bilateral infiltrates, likely from aspiration pneumonitis.The pt was in the icu for several days and later moved to the floor and followed by pulmonary service.The pt continued to have oxygen requirements at rest.The pt factors may have contributed to the event.There is not enough info about the pt's dialysis treatment history to determine their relationship to the event.However, considering the info at hand, medical records do not show a causal relationship between the hemodialysis concomitant products and the event.This product is being submitted as part of a system level review.Further additional info upon receipt will be submitted accordingly.

• Brand Name: FRESENIUS COMBISET BLOODLINES
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; cd, reynosa, tamps 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; cd, reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: corie vazquez ; 920 winter street; waltham, MA 02451 ; 7816999071
• MDR Report Key: 4780241
• MDR Text Key: 16310299
• Report Number: 8030665-2015-00246
• 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: Consumer,Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/07/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 05/18/2015
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: FMC BLOODLINES; BATH; 2008K; SALINE; DIALYZER; DEPAKOTE; CONCENTRATES; DIALYSIS FOR A FULL 3 1/2 HOURS ON A 2 POTASSIUM; OXYGEN
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 57