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

Model Number 2420-0007

Device Problem Infusion or Flow Problem (2964)

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

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

Date of birth: patient¿s birthday was not provided, (b)(6) was used based on age of patient.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that magnesium was overinfused while using the bd alaris¿ smartsite¿ low sorbing set.There was no patient impact.The following information was provided by the initial reporter: it was reported that the clinician hung magnesium 4 grams in 100ml infusion as piggyback at 10:39am, to run at 25ml/hr.At 11:34am, the bag was found empty.The nurse observed the patient to have flushed face and transient hypotension.The vital signs were within normal limits.The staff is unsure if medication back flowed into primary bag.There was a question on whether the bags were arranged at the correct heights in relation to one another.Laboratory testing was performed on the patient and revealed no negative outcomes.The repeat magnesium blood level was "1.7" (normal range for blood magnesium level is 1.7 to 2.2 mg/dl).Vital signs remained stable.There was patient involvement but no harm.

Manufacturer Narrative

Date of birth: patient¿s birthday was not provided, (b)(6) was used based on age of patient.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that magnesium was overinfused while using the bd alaris¿ smartsite¿ low sorbing set.There was no patient impact.The following information was provided by the initial reporter: it was reported that the clinician hung magnesium 4 grams in 100ml infusion as piggyback at 10:39am, to run at 25ml/hr.At 11:34am, the bag was found empty.The nurse observed the patient to have flushed face and transient hypotension.The vital signs were within normal limits.The staff is unsure if medication back flowed into primary bag.There was a question on whether the bags were arranged at the correct heights in relation to one another.Laboratory testing was performed on the patient and revealed no negative outcomes.The repeat magnesium blood level was "1.7" (normal range for blood magnesium level is 1.7 to 2.2 mg/dl).Vital signs remained stable.There was patient involvement but no harm.

Event Description

It was reported that magnesium was overinfused while using the bd alaris¿ smartsite¿ low sorbing set.There was no patient impact.The following information was provided by the initial reporter: it was reported that the clinician hung magnesium 4 grams in 100ml infusion as piggyback at 10:39am, to run at 25ml/hr.At 11:34am, the bag was found empty.The nurse observed the patient to have flushed face and transient hypotension.The vital signs were within normal limits.The staff is unsure if medication back flowed into primary bag.There was a question on whether the bags were arranged at the correct heights in relation to one another.Laboratory testing was performed on the patient and revealed no negative outcomes.The repeat magnesium blood level was "1.7" (normal range for blood magnesium level is 1.7 to 2.2 mg/dl).Vital signs remained stable.There was patient involvement but no harm.

Manufacturer Narrative

H.10 device returned to manufacturer?: yes.H.10.Date sample received?: 2022-03-16.H.6.Investigation summary: one primary set (model #2420-0007) and one non-bd secondary set were returned by the customer.It was reported that the magnesium overinfused.Fluid was found to be flowing from the secondary set into the primary line, indicating a back check valve failure.A quality notification has been sent to the supplier, and the sample has been sent for further investigation.The supplier was able to confirm back flow.Further evaluation revealed that the cover had scratches and white spots.A pressure test (water) showed a leak on the damaged side with dark and light colored embedded particulate on the disc (housing side).The particulates were identified to be calcium, carbon, and oxygen.However, these materials are not used in the design of the check valve.Disc pinch impressions were present, the diaphragm was centered.Cracking pressure test (air) passed, and all dimensional readings were within tolerance.Since the identified particulate is not from the supplier process, it can be concluded that the origin or source of these materials is unknown and the root cause for backflow could not be determined.An investigation of the manufacturing process was performed.After reviewing the process, no potential causes were found during the manufacturing process that could cause damage to the check valve, therefore the root cause of the damage is unknown.We will continue to track this issue and watch for any emerging trends.A lot for the returned sample was unknown, however, several potential lots were determined: 21076372, 21076381, 21076396, 21076397.A device history record review for model 2420-0007 and possible lot number 21076372 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 27jul2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 and possible lot number 21076381 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 27jul2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 and possible lot number 21076396 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 28jul2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 and possible lot number 21076397 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 28jul2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: BD ALARIS¿ SMARTSITE¿ LOW SORBING SET
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13113340
• MDR Text Key: 286116792
• Report Number: 9616066-2021-52655
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021020
• UDI-Public: 37613203021020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female