MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS SMARTSITE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2000E7D

Device Problem Backflow (1064)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2023

Event Type  malfunction  

Event Description

It was reported that bd alaris smartsite had blood back flow during infusion.The following information was received by the initial reporter with the verbatim: problem: backflow of blood into the line, even after a correct flush, returns blood and obstructs central peripheral insertion accesses.There have already been five events with the same batch.Additional information received on 10/24/2023: was there any harm to the patient/healthcare professional? a: the patients involved in these cases had moderate damage, where it was necessary to carry out a new procedure to insert a peripherally inserted central catheter, a risk for our neonatal patient and also a burden for our institution due to the cost of another central catheter.Was there a need for medical and/or surgical intervention due to the incident (imaging exams, surgery, medication administration, etc.)? a: there was a need for a new central catheter puncture.Was there exposure of blood or chemotherapy to mucous membranes (eyes, nose and mouth) or skin? if so, indicate whether the exposure was to the patient or the professional and what measures were taken.(details).A: no.What medication was being administered? a: serum therapy and antibiotics depend on the case, which are more than one.Is the sample contaminated? if yes, please provide the substance.A: not just with serum therapy, one sample and another from the same batch sealed.Has anvisa already been notified? if yes, what is the notification number? a: still, we will not notify you after analyzing the quality deviation.Additional information received on 13.Nov.2023.Please describe the clinical set up, including details of the products connected to either end of the 2000e7d product (manufacturer and model).Picc model: double lumen.Pump used: atb medications installed in an infusion pump (mindray), perfusion syringe and saline solution flush in a 10ml syringe in the form of a swirl (pulsatile flushing).Lot 102543.Please confirm if any physical damage or deformity was observed to the smartsite valve? there is no external defect, however, as it contains an internal valve, i do not have a technical team to carry out this check.Please confirm what fluids were being administered at the time of the event(s)? solutions administered: -vancomycin 12/12h administered time (8pm to 8am)-t azocin 8h to 8am administered time (9pm 5am to 1pm)-before and after each medication saline solution flush (0.5ml).Please confirm if any leakage was observed from the smartsite? there was no leak.Due to incompatibility between vancomycin and tazocin, we stopped vancomycin in 1 hour and then added tazocin in 3 hours, taking saline solution between medications in the evening only.Please provide details regarding the sequence of events immediately prior to the issue occurring.Sequence of events that preceded the occurrence: on (b)(6) - picc 2fr dl brand blenta (lot:201108) was inserted on left axillary vein position, central position.On (b)(6), first record of obstruction of a lumen with a valved device (ultrasitis ) - (09 days after passage of the catheter).An exclusive lumen for continuous parenteral nutrition, which did not obstruct, as it was continuously connected to the equipment, another saline lumen with a valved device (ultrasite) for administering medications for the patient.Furthermore, we had another event from the same batch, which has more information below: picc inserted on (b)(6) (double lumen, batch: 2300225) left jugular position, central position.Exclusive parenteral nutrition in one lumen and another saline lumen for atb medications (vancomycin + meronem + amphotericin), after a few days, the patient improved clinically, being suspended and leaving one lumen with saline solution and another lumen with a valved connector (ultrasitis) ¿ (b)(6).On (b)(6) one lumen was obstructed, the one with a valved connector and the other with an infusion of saline solution 0.9% at 1ml/h.Lumen without infusion, routine saline solution flush 1x/shift.Note: when the lumens are in continuous use, they do not obstruct, when the lumen is flushed with saline solution and we place the valved connector (ultrasite), blood flows back, obstructing the lumen.----> complaint captured on pr# (b)(4).Firstly, batch 1025437 had been reported for which we have occurrence 9050826.However, below it is reported that there is a sample of batch 1025436.Could you please clarify what happened with batch 1025436? regarding the other event 1025436, the same thing happened, blood flows even with the connector installed.It would be better to separate the requests because otherwise there will be confusion - i use the internal number and you others, if you need more information about the event with batch 1025436 - please request separately complaint captured on pr# (b)(4).Additional information received on 27.Nov.2023.Confirm that any physical damage or deformity is noted on the smartsite valve = visibly no deformity.Please confirm which liquids were being administered at the time of the event(s)? catheter route was flushed with saline solution and valved device.Please confirm whether any leaks have been observed on smartsite, no leaks.Provide details about the sequence of events immediately before the problem occurred.I don't remember exactly, but in the same week there were 3 patients with the same occurrence.This has stopped happening, as we are no longer using the valved device (ultrasite), we are leaving a tap in the lumen with saline solution.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

No additional information.

Manufacturer Narrative

Investigation results: no samples were received for investigation of (b)(4), in which the customer has stated: "backflow of blood into the line." this feedback relates to a 2000e7d product from lot 1025437.However, the customer did provide two photographs, analysis of which confirms the reported back flow of blood.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 1025437 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.The 2000e7d product is not a back check valve and therefore during use it may be possible for back flow to occur under certain infusion rates and clinical set-ups.When the smartsite component is accessed with a compatible male luer, it is effectively an open path, through which fluid can travel in both directions; however, when the connecting product is removed, it becomes a closed system.A review of the customer feedback database indicates that complaints of this nature are rare, and that there is currently no trend for reports of this nature against the smartsite product.

Manufacturer Narrative

If a device evaluation and/or device history review is completed, a supplemental report will be filed this supplemental is being submitted as a correction to the original with update to received by manufacturer to 11/13/2023.

Event Description

No additional information problem: backflow of blood into the line, even after a correct flush, returns blood and obstructs central peripheral insertion accesses.There have already been five events with the same batch.___ additional information received on 10/24/2023: ¿ was there any harm to the patient/healthcare professional? a: the patients involved in these cases had moderate damage, where it was necessary to carry out a new procedure to insert a peripherally inserted central catheter, a risk for our neonatal patient and also a burden for our institution due to the cost of another central catheter.¿ was there a need for medical and/or surgical intervention due to the incident (imaging exams, surgery, medication administration, etc.)? a: there was a need for a new central catheter puncture.¿ was there exposure of blood or chemotherapy to mucous membranes (eyes, nose and mouth) or skin? if so, indicate whether the exposure was to the patient or the professional and what measures were taken.(details) a: no.¿ what medication was being administered? a: serum therapy and antibiotics depend on the case, which are more than one.¿ is the sample contaminated? if yes, please provide the substance.A: not just with serum therapy, one sample and another from the same batch sealed.¿ has anvisa already been notified? if yes, what is the notification number? a: still, we will not notify you after analyzing the quality deviation.__ additional information received on 13.Nov.2023.Please describe the clinical set up, including details of the products connected to either end of the 2000e7d product (manufacturer and model) = picc model: double lumen.Pump used: atb medications installed in an infusion pump (mindray), perfusion syringe and saline solution flush in a 10ml syringe in the form of a swirl (pulsatile flushing).Lot 102543.Please confirm if any physical damage or deformity was observed to the smartsite valve? there is no external defect, however, as it contains an internal valve, i do not have a technical team to carry out this check.Please confirm what fluids were being administered at the time of the event(s)? = solutions administered: -vancomycin 12/12h administered time (8pm to 8am)-t azocin 8h to 8am administered time (9pm 5am to 1pm)-before and after each medication saline solution flush (0.5ml) please confirm if any leakage was observed from the smartsite? there was no leak.Due to incompatibility between vancomycin and tazocin, we stopped vancomycin in 1 hour and then added tazocin in 3 hours, taking saline solution between medications in the evening only.Please provide details regarding the sequence of events immediately prior to the issue occurring = sequence of events that preceded the occurrence: on 19/09 - picc 2fr dl brand blenta (lot:201108) was inserted on left axillary vein position, central position.On 28/09, first record of obstruction of a lumen with a valved device (ultrasitis ) - (09 days after passage of the catheter).An exclusive lumen for continuous parenteral nutrition, which did not obstruct, as it was continuously connected to the equipment, another saline lumen with a valved device (ultrasite) for administering medications for the patient.Furthermore, we had another event from the same batch, which has more information below: picc inserted on 09/22 (double lumen, batch: 2300225) left jugular position, central position.Exclusive parenteral nutrition in one lumen and another saline lumen for atb medications (vancomycin + meronem + amphotericin), after a few days, the patient improved clinically, being suspended and leaving one lumen with saline solution and another lumen with a valved connector (ultrasitis) ¿ 09/29.On 09/30, one lumen was obstructed, the one with a valved connector and the other with an infusion of saline solution 0.9% at 1ml/h.Lumen without infusion, routine saline solution flush 1x/shift.Note: when the lumens are in continuous use, they do not obstruct, when the lumen is flushed with saline solution and we place the valved connector (ultrasite), blood flows back, obstructing the lumen.----> complaint captured on (b)(4).- firstly, batch 1025437 had been reported for which we have occurrence (b)(6), however, below it is reported that there is a sample of batch 1025436.Could you please clarify what happened with batch 1025436? regarding the other event 1025436, the same thing happened, blood flows even with the connector installed.It would be better to separate the requests because otherwise there will be confusion - i use the internal number and you others, if you need more information about the event with batch 1025436 - please request separately ---> complaint captured on (b)(4).___ additional information received on 27.Nov.2023.Confirm that any physical damage or deformity is noted on the smartsite valve = visibly no deformity.Please confirm which liquids were being administered at the time of the event(s)? = catheter route was flushed with saline solution and valved device.Please confirm whether any leaks have been observed on smartsite = no leaks provide details about the sequence of events immediately before the problem occurred = i don't remember exactly, but in the same week there were 3 patients with the same occurrence.This has stopped happening, as we are no longer using the valved device (ultrasite), we are leaving a tap in the lumen with saline solution.

Event Description

No additional information.

Manufacturer Narrative

Updated investigation after physical sample received: two 2000e7d samples were received for investigation of (b)(4), in which the customer has stated: "backflow of blood into the line, even after a correct flush, returns blood and obstructs central peripheral insertion accesses." of the two samples received, one was received without packaging but with no signs of having been in clinical use as no residual fluid was present; whilst the second sample was received in sealed packaging from lot 1025437.No sample of the connecting product(s) was received to aid the investigation.Examination of the returned samples did not identify any visual damage or manufacturing defects which might explain the customer's experience.Additionally, both samples were successfully accessed and flushed using a bd plastipak syringe; no leakage or air ingress was observed when back pressure was applied.Although the customer's report was not confirmed with the samples provided, the customer did provide two photographs (appendices 1 & 2), analysis of which confirms the reported back flow of blood.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 1025437 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.Please note that the 2000e7d product is not a back check valve and therefore during use it may be possible for back flow to occur under certain infusion rates and clinical set-ups.When the smartsite component is accessed with a compatible male luer, it is effectively an open path, through which fluid can travel in both directions; however, when the connecting product is removed, it becomes a closed system.Please note, bd has a range of products which may help to overcome this type of issue including a range of smartsite extension sets with clamps.A review of the customer feedback database indicates that complaints of this nature are rare, and that there is currently no trend for reports of this nature against the smartsite product.

• Brand Name: BD ALARIS SMARTSITE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18248654
• MDR Text Key: 330559275
• Report Number: 9616066-2023-02312
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203013629
• UDI-Public: (01)37613203013629
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2000E7D
• Device Lot Number: 1025437
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 11/13/2023; 12/12/2023; 03/12/2024
• Supplement Dates FDA Received: 12/05/2023; 12/14/2023; 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1