MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INFUSION

Model Number 10807851

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Rash (2033); Skin Irritation (2076); Swelling (2091)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

Photo- provided of the filter set with brown sediment - set not sequestered.Ethnicity: not hispanic/latino.Elderly male with paroxysmal atrial fibrillation, hypertension, and chronic kidney disease who was admitted for circulatory shock and found to have mssa bacteremia.

Event Description

Customer advocacy received a copy of the customer's medwatch report from the fda which states, "elderly male with paroxysmal atrial fibrillation, hypertension, and chronic kidney disease who was admitted for circulatory shock and found to have mssa bacteremia.Pt reported sudden onset of facial swelling and he also had rashes on bilateral le, erythematous spots which are not raised and not itchy his left arm was swollen at the iv site {at the site of his amiodarone infusion) and amiodarone tubing filter is noted with significant brown sediment.Pt has tolerated amiodrone previously prior to switching to sotalol after 2 months of therapy chart notes without edits "pt noted increased lip swelling and spotty macular rash which slowly improved throughout the day and is nearly resolved the next morning no other swelling in the face or tongue no difficulty with managing secretions or difficulty speaking the only two new medications he took the day before were imodium and melatonin, neither of which are thought to be high risk for hypersensitivity amio filter did have some particulate matter in it worth mentioning that he was on steroids until 2 days before, which may have been masking other medication side-effects"." other therapies used on the patient at the time of the event that may have caused or contributed to the event pt had allergic reaction and the rn noticed brown sediments in the care fusion extension set filter.Etiology is unclear (drug incompatibility or contaminant) tubing sent for culture, no microbial growth.The patient was on cefazolin and magnesium sulfate both of which could have resulted m an incompatibility the patient was also on pcn and sodium phosphate but these were discontinued prior to occurrence.Other information about the patient that may have influenced the outcome of the event.Excerpt from epic without edits "pt noted increased lip swelling and spotty macular rash on lower extremities on morning of 8/5 no other swelling m the face or tongue no difficulty with managing secretions or difficulty speaking the only two new medications he took on 8/4 were imodium and melatonin, neither of which are though to be high risk for hypersensitivity ,amio filter did have some particulate matter in it (^contaminant,incompatibility7} amio tubing is being cultured but suspect this will not yield the cause of his reaction worth mentioning that he was on steroids through 8/3 which may have been masking other medication side effects (digoxin m particular is concerning possibility) amio switched to po and digoxin discontinued and symptoms improved throughout the day and resolved by the next morning" it was reported at 0711a amiodarone infusion was programmed rate 16.7ml/hr.When patient experienced a reaction.The user noted that the amiodarone tubing with filter had a significant amount of brown sediment.The results of the specimen collected from the filter was confirmed with no growth presence.The rn stated; ¿it¿s unclear/unable to identify the cause of allergic reaction".The event occurred on the cardiology unit.

Event Description

Customer advocacy received a copy of the customer's medwatch report from the fda which states, "elderly male with paroxysmal atrial fibrillation, hypertension, and chronic kidney disease who was admitted for circulatory shock and found to have mssa bacteremia.Pt reported sudden onset of facial swelling and he also had rashes on bilateral le, erythematous spots which are not raised and not itchy.His left arm was swollen at the iv site {at the site of his amiodarone infusion) and amiodarone tubing filter is noted with significant brown sediment.Pt has tolerated amiodrone previously prior to switching to sotalol after 2 months of therapy chart notes without edits "pt noted increased lip swelling and spotty macular rash which slowly improved throughout the day and is nearly resolved the next morning no other swelling in the face or tongue.No difficulty with managing secretions or difficulty speaking.The only two new medications he took the day before were imodium and melatonin, neither of which are thought to be high risk for hypersensitivity.Amio filter did have some particulate matter in it.Worth mentioning that he was on steroids until 2 days before, which may have been masking other medication side-effects"." other therapies used on the patient at the time of the event that may have caused or contributed to the event.Pt had allergic reaction and the rn noticed brown sediments in the care fusion extension set filter.Etiology is unclear (drug incompatibility or contaminant).Tubing sent for culture, no microbial growth.The patient was on cefazolin and magnesium sulfate both of which could have resulted (in) an incompatibility.The patient was also on pcn and sodium phosphate but these were discontinued prior to occurrence.Other information about the patient that may have influenced the outcome of the event; excerpt from epic without edits "pt noted increased lip swelling and spotty macular rash on lower extremities on morning of 8/5.No other swelling on the face or tongue.No difficulty with managing secretions or difficulty speaking.The only two new medications he took on 8/4 were imodium and melatonin, neither of which are though to be high risk for hypersensitivity.Amio filter did have some particulate matter in it (^contaminant, incompatibility7} amio tubing is being cultured but suspect this will not yield the cause of his reaction.Worth mentioning that he was on steroids through 8/3 which may have been masking other medication side effects (digoxin m particular is concerning possibility).Amio switched to po and digoxin discontinued and symptoms improved throughout the day and resolved by the next morning".It was reported at 0711a, amiodarone infusion was programmed rate 16.7ml/hr.When patient experienced a reaction.The user noted that the amiodarone tubing with filter had a significant amount of brown sediment.The results of the specimen collected from the filter was confirmed with no growth presence.The rn stated; ¿it¿s unclear/unable to identify the cause of allergic reaction".The event occurred on the cardiology unit.

Manufacturer Narrative

No product will be returned.Photo provided by the customer shows brown contamination embedded inside the micron filter membrane.The root cause of this failure was not identified.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9278685
• MDR Text Key: 202551461
• Report Number: 9616066-2019-03058
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403234446
• UDI-Public: 10885403234446
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10807851
• Device Catalogue Number: 10807851
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRI TUBING,(2) SEC TUBING , TD 01/01/2019
• Patient Age: 68 YR
• Patient Weight: 87