MAUDE Adverse Event Report: CAREFUSION, INC UKNOWN CHLORAPREP; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number UNKNOWN

Device Problem Defective Component (2292)

Patient Problem Unspecified Infection (1930)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

Bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

Material no: unknown batch no: unknown it was reported that the aim of the study was to test whether the introduction of disinfection with 2% chlorhexidine gluconate (chg) and 70% isopropyl alcohol (ipa) of the exposed circuits and hub in patients treated with ecmo would affect the rate of blood stream infection (bsi) and microbial colonization of the ecmo catheter.Outcomes of the study was sepsis-related death, ecmo bloodstream infection, ecmo catheter culture positive and oxygenator culture positive.Event description per attached email states: other serious criteria: medically significant sepsis-related death [sepsis] ecmo blood stream infection [systemic infection] catheter-related bloodstream infection [device related infection] ecmo catheter culture positive [catheter culture positive] oxygenator culture positive [culture positive] case description: yeo hye ju, kim dohyung, ha mihyang, gon je hyung, kim jeong soo and cho woo hyun: chlorhexidine bathing of the exposed circuits in extracorporeal membrane oxygenation: an uncontrolled before-and after study.Critical care 2020; 24:595.Case reference number kp-bd-20-007605 is a literature case, title as stated above, identified on 21-dec-2020 and concerns multiple patients.Total of 192 patients (older than 18 years, mean age: 58 ¿ 14.4 years), who required extracorporeal membrane oxygenation (ecmo) for cardiogenic or respiratory failure, were enrolled in uncontrolled, single center, before-and-after study.The aim of the study was to test whether the introduction of disinfection with 2% chlorhexidine gluconate (chg) and 70% isopropyl alcohol (ipa) of the exposed circuits and hub in patients treated with ecmo would affect the rate of blood stream infection (bsi) and microbial colonization of the ecmo catheter.The intervention and control group each had 96 eligible patients enrolled during the study period.Microbiological and clinical data before and after the intervention were compared between intervention and control group.During the pre-intervention period, standard practice was for all ecmo patients to receive daily 2% chlorhecidine gluconate (brand name unknown) disinfection at the ecmo catheter insertion site according to the infection precaution policy of the hospital.Basically, all patients with central lines received daily 2% chg bathing to clean neck and chest.The dialysis line was connected to the ecmo hub when rrt was required during ecmo, and post-membrane blood gas analysis was performed when oxygenator dysfunction was suspected.Also, oxygenator was exchanged when oxygenator dysfunction or massive clot was observed.The primary outcome was the incidence of bsi during ecmo.Secondary outcomes were colonization of ecmo catheters, overall mortality, sepsis-related death, ecmo complications, and microbiology of catheter colonization.Catheter colonization was defined as a positive culture of ecmo catheters at the time of removal.Other central venous catheter-related infections were defined by the clinical practice guidelines of the infectious disease society of america (idsa).The catheter samples were harvested aseptically and prospectively collected and cultured at the end of ecmo support.After removal, the sections (5 cm) were cut from the intravascular region, split longitudinally, and immediately transported to the laboratory.The oxygenator membranes were also harvested aseptically and prospectively collected and cultured.The membrane oxygenator was rinsed through the tube system with sterile physiological saline solution (0.9% w/v nacl, twice) to remove blood.Subsequently, it was opened under sterile conditions.A hollow fiber membrane smear was taken from the opened membrane oxygenator, using a sterile swab.The catheter segments and oxygenator swab were submitted to the local microbiology laboratories for routine culture and antibiogram.Blood culture samples from patients at the time of catheter removal underwent standard culture methods.Bacterial growth from oxygenator swab cultures was assessed using a semi-quantitative method.The intervention of disinfection with 2% chg/ipa of exposed circuits and hub significantly decreased the incidence of bsi during ecmo from 11.7/1000 ecmo catheter days to 2.3/1000 ecmo catheter days (difference 9.4, 95% ci 1.5-17.3, p = 0.019) in the study period.As well, the incidence of ecmo catheter colonization was significantly higher in the control group (10.5/1000 ecmo catheter days vs.2.3/1000 ecmo catheter days (difference 8.3, 95% ci 0.7-15.8, p = 0.032).The positive rate of oxygenator culture was higher in the control group (14% vs.1.1%, p = 0.002).The incidence of ventilator-associated pneumonia (vap) was higher in the control group (25.7% vs.10.2%, p = 0.016).Other central venous catheter-related bsi was higher in the control group (21.1% vs.7.9%, p = 0.023).Hospital mortality (41.7% vs.24%, p = 0.009) and sepsis-related death (17.7% vs.6.3%, p = 0.014) were also significantly decreased during intervention.In this study, 4 out of the 12 patients who had bsi during ecmo died of sepsis.In this study, the incidence of bsi and ecmo catheter colonization was significantly lower in the intervention group.Furthermore, overall mortality and sepsis-related mortality was significantly lower in the intervention group.This inexpensive and readily available intervention, disinfection with 2% chlorhexidine gluconate of all exposed circuits and hubs, has the potential to reduce the bsi rate of patients on ecmo.Authors comment: in this uncontrolled before-and-after study, the chlorhexidine bathing of exposed circuits and hub was significantly associated with lower incidence of bsi during ecmo.As well, the incidence of ecmo catheter colonization was lower, especially in gram-positive pathogens.The intervention group showed lower overall and sepsis-related mortality without any adverse effect after the intervention.This intervention could be a simple, effective strategy to decrease the bsi on ecmo.Case comment: patients treated topically with chloraprep experienced sepsis, extracorporeal membrane oxygenation (ecmo) blood stream infection, catheter-related bloodstream infection, ecmo catheter culture positive and oxygenator culture positive.Long-term ecmo support, intervention, renal replacement therapy during ecmo and oxygenator exchange were significantly associated with reported events.No information was provided regarding medical history and clinical course of individual patient which could additionally confounded reported events.However, as the contributory role of chlorhexidine cannot be excluded, causality for all events is assessed as possibly related to chlorhexidine.The case is serious due to fatal outcome related to sepsis and medical significance of the events systemic infection/ ecmo blood stream infection and device related infection/ catheter-related bloodstream infection.

• Brand Name: UKNOWN CHLORAPREP
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 11117844
• MDR Text Key: 225118197
• Report Number: 3004932373-2020-00171
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2020

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: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other