| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Bacterial Infection (1735); Death (1802)
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| Event Date 01/29/2020 |
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Event Type
Death
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that an unspecified posifiush heparin lock flush syringes or pre-filled normal saline syringes was used on a patient who contracted serratia marcescens bacteria and passed away.The following information was provided by the initial reporter: verbatim: it was reported that posifiush heparin lock flush syringes or pre-filled normal saline syringes was used on a patient who contracted serratia marcescens bacteria and passed away.The incident happened on or about (b)(6) 2018.The reporter alleges that the patient passed away as a result of being exposed to serratia marcescens bacteria.
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Manufacturer Narrative
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Correction: the mdr was filed prematurely as a 5 day reportable complaint when in fact it is a 30 day reportable complaint.Infection would lead to harm of the client.This would require medical intervention as the result could lead to possible systemic injury or death to the patient.The complaint has been filed as death.An official investigation will be needed to conclude whether or not the product /devices are responsible for the clients death.H3 other text : see section h.10.
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Event Description
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It was reported that an unspecified posifiush heparin lock flush syringes or pre-filled normal saline syringes was used on a patient who contracted serratia marcescens bacteria and passed away.The following information was provided by the initial reporter: verbatim: it was reported that posifiush heparin lock flush syringes or pre-filled normal saline syringes was used on a patient who contracted serratia marcescens bacteria and passed away.The incident happened on or about (b)(6) 2018.The reporter alleges that the patient passed away as a result of being exposed to serratia marcescens bacteria.
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Event Description
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It was reported that an unspecified posifiush heparin lock flush syringes or pre-filled normal saline syringes was used on a patient who contracted serratia marcescens bacteria and passed away.The following information was provided by the initial reporter: verbatim: it was reported that posifiush heparin lock flush syringes or pre-filled normal saline syringes was used on a patient who contracted serratia marcescens bacteria and passed away.The incident happened on or about (b)(6) 2018.The reporter alleges that the patient passed away as a result of being exposed to serratia marcescens bacteria.Information below was taken from the attached ¿service of process transmittal¿: on february 8, 2018, plantiff¿s decedent, (pt name redacted), was admitted at which time he underwent a procedure in the cardiac catheterization laboratory wherein an intra-aortic balloon pump[hereinafter ¿iab pump¿] was inserted into his aorta.Immediately following the cardiac catheterization laboratory procedure, (pt name redacted), was admitted to critical care unit (formerly known as the intensive care unit).(pt name redacted) remained a patient in from the time of his admission on (b)(6) 2018 until he was transferred to another facility on (b)(6) 2018.In the late afternoon/early evening hours of (b)(6) 2018, (pt name redacted), underwent a six (6) vessel coronary artery bypass grafting surgery at which surgery is documented to have concluded at 8:10 p.M.After surgery, (pt name redacted), was returned to the critical care unit at approximately 9:38 p.M.Upon his return to the critical care unit, (pt name redacted) began to experience severe tachycardia and shock which manifested as rapid and aggressive lactic acidosis.According to a progress note entered at 3:36 a.M.On (b)(6) 2018 she was called to the critical care unit by nurses at approximately 00:44 a.M.To respond to (pt name redacted) worsening condition.Upon examination, the health care provider focused upon the positioning of the iam pump despite the cardiovascular surgeon¿s confirmation that the iab pump¿s position was stable.Upon examination, the health c are provider did not record the possibility of infection as a considered cause of (pt name redacted) worsening condition.After examination,the healthcare provider diagnosed (pt name redacted) with shock and lactic acidosis.The health care provider did not order antibiotics to address a possible infection.The healthcare provider did not seek an infectious disease consultation.(pt name redacted) condition continued to rapidly deteriorate and he was taken to surgery at approximately 7:35 a.M.On (b)(6) 2018 at which time an exploratory laparotomy was performed that ruled out bowel ischemia.Post exploratory laparotomy, (pt name redacted) was returned to the critical care unit where his condition continued to deteriorate.With the critical care team having failed to order blood cultures to ascertain if (pt name redacted) deteriorating condition was cause or contributed to by an infection, the cardiovascular team ordered blood cultures at 11:40 a.M.And 11:41 a.M.Preliminary blood culture results documented at 1:30 p.M.And 2:40 p.M.Indicated that the presence of gram negative rods, and more specifically, serratia marcescens bacteria.Records indicate that these preliminary blood culture test results were simultaneously provided to the critical care team nursing staff.Neither of the healthcare providers ordered any form of intervention or antibiotics to address (pt name redacted) deteriorating condition in light of the preliminary blood culture results which indicated serratia marcescens infection was the underlying source of (pt name redacted) deteriorating condition.The doctor documented his involvement in the care and treatment provided to (pt name redacted) in a (b)(6) 2018 progress note entered at 6:41 p.M., the interval history disposition portions of which largely mimicked the healthcare providers 3:36 a.M.Progress note and again, placed emphasis on the position of the iab pump, a concern previously negated by the cardiovascular surgeon.The doctor's progress note failes to acknowledge or address the preliminary blood culture results indicating the presence of serratia marcescens infection reported nearly four (4) hours earlier.The doctor's progress note included diagnosis of respiratory failure, post-0operative, shock, lactic acidosis and septic arthritis of the elbow.The doctor did not initiate any type of treatment protocol; instead he simply directed serial laboratory studies and radiologic imaging designed to monitor (pt name redacted) condition.The preliminary blood culture results indicating the presence of serratia marcescens bacteria in (pt name redacted) blood stream were subsequently confirmed, which confirmation was called to the critical care team nursing staff at 11:10 p.M.On (b)(6) 2018.On (b)(6) 2018, (pt name redacted) underwent another surgery to remove all catheters, internal lines and the iab pump.The catheters, internal lines and iab pump removed from (pt name redacted) body during the (b)(6) 2018 surgery were cultured and all tested positive for the presence of serratia marcescens bacteria.After the (b)(6) 2018 surgery, (pt name redacted) was returned to the critical care unit where he remained under the care of the critical care team, including its nursing staff, and others who were not consulting on (pt name redacted) case.(pt name redacted) condition continued to deteriorate and, on (b)(6) 2018, he was transferred to west penn hospital in pittsburgh, pennsylvania on an urgent basis.Upon his admission the attending physician noted that (pt name redacted) was ¿hypercrictically ill,¿ that he was in a ¿non-survival situation¿ and that resuscitation efforts would be ¿futile.¿ the hospital records also noted that decedent (pt name redacted) presented with ¿septic shock secondary to serratia marcescens isolated from blood stream infection.¿ less than four (4) hours after his admission to the hospital, (pt name redacted) died at 12:23 a.M.On (b)(6) 2018.(pt name redacted) death certificate documents his cause of death as septic shock secondary to serratia bacteremia.
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Manufacturer Narrative
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Investigation: although retain samples are available for all lots manufactured in franklin, as the lot number was not provided, retain samples were not tested.A review of all lot sterility testing performed for product released between april 2015 & may 2018 confirmed that no organism growth was identified for any lots released during the shelf-life of this product.The root cause analysis of the reported infection cases under capa 350041 has not identified a direct causation between the infections and the bd franklin product.
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Manufacturer Narrative
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Additional information was received from the customer.The following fields have been updated: b.5- it was reported that an unspecified posifiush heparin lock flush syringes or pre-filled normal saline syringes was used on a patient who contracted serratia marcescens bacteria and passed away.The following information was provided by the initial reporter: verbatim: it was reported that posifiush heparin lock flush syringes or pre-filled normal saline syringes was used on a patient who contracted serratia marcescens bacteria and passed away.The incident happened on or about (b)(6) 2018.The reporter alleges that the patient passed away as a result of being exposed to serratia marcescens bacteria.Information below was taken from the attached ¿service of process transmittal¿: on (b)(6) 2018, plaintiff¿s decedent, (pt name redacted), was admitted at which time he underwent a procedure in the cardiac catheterization laboratory wherein an intra-aortic balloon pump[hereinafter ¿iab pump¿] was inserted into his aorta.Immediately following the cardiac catheterization laboratory procedure, (pt name redacted), was admitted to critical care unit (formerly known as the intensive care unit).(pt name redacted) remained a patient in from the time of his admission on (b)(6) 2018 until he was transferred to another facility on (b)(6) 2018.In the late afternoon/early evening hours of (b)(6) 2018, (pt name redacted), underwent a six (6) vessel coronary artery bypass grafting surgery at which surgery is documented to have concluded at 8:10 p.M.After surgery, (pt name redacted), was returned to the critical care unit at approximately 9:38 p.M.Upon his return to the critical care unit, (pt name redacted) began to experience severe tachycardia and shock which manifested as rapid and aggressive lactic acidosis.According to a progress note entered at 3:36 a.M.On (b)(6) 2018 she was called to the critical care unit by nurses at approximately 00:44 a.M.To respond to (pt name redacted) worsening condition.Upon examination, the health care provider focused upon the positioning of the iam pump despite the cardiovascular surgeon¿s confirmation that the iab pump¿s position was stable.Upon examination, the health c are provider did not record the possibility of infection as a considered cause of (pt name redacted) worsening condition.After examination,the healthcare provider diagnosed (pt name redacted) with shock and lactic acidosis.The health care provider did not order antibiotics to address a possible infection.The healthcare provider did not seek an infectious disease consultation.(pt name redacted) condition continued to rapidly deteriorate and he was taken to surgery at approximately 7:35 a.M.On (b)(6) 2018 at which time an exploratory laparotomy was performed that ruled out bowel ischemia.Post exploratory laparotomy, (pt name redacted) was returned to the critical care unit where his condition continued to deteriorate.With the critical care team having failed to order blood cultures to ascertain if (pt name redacted) deteriorating condition was cause or contributed to by an infection, the cardiovascular team ordered blood cultures at 11:40 a.M.And 11:41 a.M.Preliminary blood culture results documented at 1:30 p.M.And 2:40 p.M.Indicated that the presence of gram negative rods, and more specifically, serratia marcescens bacteria.Records indicate that these preliminary blood culture test results were simultaneously provided to the critical care team nursing staff.Neither of the healthcare providers ordered any form of intervention or antibiotics to address (pt name redacted) deteriorating condition in light of the preliminary blood culture results which indicated serratia marcescens infection was the underlying source of (pt name redacted) deteriorating condition.The doctor documented his involvement in the care and treatment provided to (pt name redacted) in a (b)(6) 2018 progress note entered at 6:41 p.M., the interval history disposition portions of which largely mimicked the healthcare providers 3:36 a.M.Progress note and again, placed emphasis on the position of the iab pump, a concern previously negated by the cardiovascular surgeon.The doctor's progress note failes to acknowledge or address the preliminary blood culture results indicating the presence of serratia marcescens infection reported nearly four (4) hours earlier.The doctor's progress note included diagnosis of respiratory failure, post-0operative, shock, lactic acidosis and septic arthritis of the elbow.The doctor did not initiate any type of treatment protocol; instead he simply directed serial laboratory studies and radiologic imaging designed to monitor (pt name redacted) condition.The preliminary blood culture results indicating the presence of serratia marcescens bacteria in (pt name redacted) blood stream were subsequently confirmed, which confirmation was called to the critical care team nursing staff at 11:10 p.M.On (b)(6) 2018.On (b)(6) 2018, (pt name redacted) underwent another surgery to remove all catheters, internal lines and the iab pump.The catheters, internal lines and iab pump removed from (pt name redacted) body during the (b)(6) 2018 surgery were cultured and all tested positive for the presence of serratia marcescens bacteria.After the (b)(6) 2018 surgery, (pt name redacted) was returned to the critical care unit where he remained under the care of the critical care team, including its nursing staff, and others who were not consulting on (pt name redacted) case.(pt name redacted) condition continued to deteriorate and, on (b)(6) 2018, he was transferred to (b)(6) hospital in (b)(6) on an urgent basis.Upon his admission the attending physician noted that (pt name redacted) was ¿hypercrictically ill,¿ that he was in a ¿non-survival situation¿ and that resuscitation efforts would be ¿futile.¿ the hospital records also noted that decedent (pt name redacted) presented with ¿septic shock secondary to serratia marcescens isolated from blood stream infection.¿ less than four (4) hours after his admission to the hospital, (pt name redacted) died at 12:23 a.M.On (b)(6) 2018.(pt name redacted) death certificate documents his cause of death as septic shock secondary to serratia bacteremia.
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Event Description
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It was reported that an unspecified posifiush heparin lock flush syringes or pre-filled normal saline syringes was used on a patient who contracted serratia marcescens bacteria and passed away.The following information was provided by the initial reporter: verbatim: it was reported that posifiush heparin lock flush syringes or pre-filled normal saline syringes was used on a patient who contracted serratia marcescens bacteria and passed away.The incident happened on or about (b)(6) 2018.The reporter alleges that the patient passed away as a result of being exposed to serratia marcescens bacteria.Information below was taken from the attached ¿service of process transmittal¿: on (b)(6) 2018, plaintiff¿s decedent, (pt name redacted), was admitted at which time he underwent a procedure in the cardiac catheterization laboratory wherein an intra-aortic balloon pump[hereinafter ¿iab pump¿] was inserted into his aorta.Immediately following the cardiac catheterization laboratory procedure, (pt name redacted), was admitted to critical care unit (formerly known as the intensive care unit).(pt name redacted) remained a patient in from the time of his admission on (b)(6) 2018 until he was transferred to another facility on (b)(6) 2018.In the late afternoon/early evening hours of (b)(6) 2018, (pt name redacted), underwent a six (6) vessel coronary artery bypass grafting surgery at which surgery is documented to have concluded at 8:10 p.M.After surgery, (pt name redacted), was returned to the critical care unit at approximately 9:38 p.M.Upon his return to the critical care unit, (pt name redacted) began to experience severe tachycardia and shock which manifested as rapid and aggressive lactic acidosis.According to a progress note entered at 3:36 a.M.On (b)(6) 2018 she was called to the critical care unit by nurses at approximately 00:44 a.M.To respond to (pt name redacted) worsening condition.Upon examination, the health care provider focused upon the positioning of the iam pump despite the cardiovascular surgeon¿s confirmation that the iab pump¿s position was stable.Upon examination, the health c are provider did not record the possibility of infection as a considered cause of (pt name redacted) worsening condition.After examination,the healthcare provider diagnosed (pt name redacted) with shock and lactic acidosis.The health care provider did not order antibiotics to address a possible infection.The healthcare provider did not seek an infectious disease consultation.(pt name redacted) condition continued to rapidly deteriorate and he was taken to surgery at approximately 7:35 a.M.On (b)(6) 2018 at which time an exploratory laparotomy was performed that ruled out bowel ischemia.Post exploratory laparotomy, (pt name redacted) was returned to the critical care unit where his condition continued to deteriorate.With the critical care team having failed to order blood cultures to ascertain if (pt name redacted) deteriorating condition was cause or contributed to by an infection, the cardiovascular team ordered blood cultures at 11:40 a.M.And 11:41 a.M.Preliminary blood culture results documented at 1:30 p.M.And 2:40 p.M.Indicated that the presence of gram negative rods, and more specifically, serratia marcescens bacteria.Records indicate that these preliminary blood culture test results were simultaneously provided to the critical care team nursing staff.Neither of the healthcare providers ordered any form of intervention or antibiotics to address (pt name redacted) deteriorating condition in light of the preliminary blood culture results which indicated serratia marcescens infection was the underlying source of (pt name redacted) deteriorating condition.The doctor documented his involvement in the care and treatment provided to (pt name redacted) in a (b)(6) 2018 progress note entered at 6:41 p.M., the interval history disposition portions of which largely mimicked the healthcare providers 3:36 a.M.Progress note and again, placed emphasis on the position of the iab pump, a concern previously negated by the cardiovascular surgeon.The doctor's progress note failes to acknowledge or address the preliminary blood culture results indicating the presence of serratia marcescens infection reported nearly four (4) hours earlier.The doctor's progress note included diagnosis of respiratory failure, post-operative, shock, lactic acidosis and septic arthritis of the elbow.The doctor did not initiate any type of treatment protocol; instead he simply directed serial laboratory studies and radiologic imaging designed to monitor (pt name redacted) condition.The preliminary blood culture results indicating the presence of serratia marcescens bacteria in (pt name redacted) blood stream were subsequently confirmed, which confirmation was called to the critical care team nursing staff at 11:10 p.M.On (b)(6) 2018.On (b)(6) 2018, (pt name redacted) underwent another surgery to remove all catheters, internal lines and the iab pump.The catheters, internal lines and iab pump removed from (pt name redacted) body during the (b)(6) 2018 surgery were cultured and all tested positive for the presence of serratia marcescens bacteria.After the (b)(6) 2018 surgery, (pt name redacted) was returned to the critical care unit where he remained under the care of the critical care team, including its nursing staff, and others who were not consulting on (pt name redacted) case.(pt name redacted) condition continued to deteriorate and, on (b)(6) 2018, he was transferred to (b)(6) hospital in (b)(6) on an urgent basis.Upon his admission the attending physician noted that (pt name redacted) was ¿hypercrictically ill,¿ that he was in a ¿non-survival situation¿ and that resuscitation efforts would be ¿futile.¿ the hospital records also noted that decedent (pt name redacted) presented with ¿septic shock secondary to serratia marcescens isolated from blood stream infection.¿ less than four (4) hours after his admission to the hospital, (pt name redacted) died at 12:23 a.M.On (b)(6) 2018.(pt name redacted) death certificate documents his cause of death as septic shock secondary to serratia bacteremia.
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Search Alerts/Recalls
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