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

Catalog Number 2420-0007

Device Problems Defective Component (2292); Air/Gas in Device (4062)

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

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that unspecified bd infusion set was damaged the following information was received by the initial reporter with the verbatim occurrence date: (b)(6).Time: 1600.Product issue: bd alaris pump infusion set: leaking noted in primary pump tubing.(packaging was not saved ¿ unable to provide a lot number, but tubing available to send for investigations).Patient in chemo suite for rituximab infusion, (secondary tubing used to administer rituximab in 250ml bag n/s).Primary line ¿ pump tubing ¿ 500 ml ns.Rituximab infusion rate at 128ml/hr.Towards end of infusion pump alarm beeping ¿air in line¿ ¿ see photo below.Rn assessed tubing, when chamber opened noted that there were pockets of air in the line, as well noted the line to be wet with clear fluid.While observing; a bubble of fluid was found to be seeping outside of the tubing (see photo below), indicating that a hole was present in the tubing that was present inside the pump chamber.Approx 10 ml of medication (rituximab) left in primary iv line (secondary line with medication removed).Primary line removed from patient and saved in cytotoxic safe bag to be sent for investigation.

Manufacturer Narrative

It was reported by customer that when rn assessed tubing, when chamber opened noted that there were pockets of air in the line, as well noted the line to be wet with clear fluid.While observing; a bubble of fluid was found to be seeping outside of the tubing, indicating that a hole was present in the tubing that was present inside the pump chamber.One sample and one photo of material number 2420-0007 was submitted for quality investigation.Visual examination of the sample was conducted to determine if there were any damages or abnormalities found on the infusion set.There were no issues visually identified on the set.The set was then primed to see if there was any leakage noticeable.Leakage was seen coming from the silicone tubing of the pumping segment.The customer complaint of component damage - leak was confirmed.Based on the location and orientation of the damages on the silicone pumping segment, the probable root cause to the damage is an incorrect insertion of the pumping segment into the pump.If the silicone tubing pumping segment is incorrectly loaded and the door is closed, holes can be punctured into the tubing causing the holes seen in this complaint.The failure was communicated to the manufacturing location, and due to the customer not identifying the leak prior to the infusion set being loaded into the alaris pump, a manufacturing issue can be eliminated as the cause of the failure.The bd clinical team has been made aware and will be in contact with the customer to determine if further training or instruction is necessary for the proper use of the product.The customer reported the material number and lot number as unknown.Through tracing the smartsite identification, the following device history review is based on the material number and lot number combinations identified.A device history record review for model 2420-0007 lot number 23105503 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 24oct2023.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 lot number 23115215 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 14nov2023.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 lot number 23115352 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 21nov2023.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 lot number 23115363 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 21nov2023.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 lot number 23115364 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 21nov2023.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.

Event Description

No additional information was provided.Material#: 2420-0007, batch number#: unknown.It was reported by customer that when rn assessed tubing, when chamber opened noted that there were pockets of air in the line, as well noted the line to be wet with clear fluid.While observing; a bubble of fluid was found to be seeping outside of the tubing (see photo below), indicating that a hole was present in the tubing that was present inside the pump chamber.Verbatim#: rcc received a complaint via email.Email(s) attached.Occurrence date: january 17th.Time: 1600.Product issue: bd alaris pump infusion set: leaking noted in primary pump tubing.(packaging was not saved ¿ unable to provide a lot number, but tubing available to send for investigations).Patient in chemo suite for rituximab infusion, (secondary tubing used to administer rituximab in 250ml bag n/s).Primary line ¿ pump tubing ¿ 500 ml ns.Rituximab infusion rate at 128ml/hr.Towards end of infusion pump alarm beeping ¿air in line¿ ¿ see photo below.Rn assessed tubing, when chamber opened noted that there were pockets of air in the line, as well noted the line to be wet with clear fluid.While observing; a bubble of fluid was found to be seeping outside of the tubing (see photo below), indicating that a hole was present in the tubing that was present inside the pump chamber.Approx 10 ml of medication (rituximab) left in primary iv line (secondary line with medication removed).Primary line removed from patient and saved in cytotoxic safe bag to be sent for investigation.Customer reply: please share the material number & lot number.Bd alaris pump tubing / infusion set.Packaging was not saved so unable to clearing identify the lot number.Describe any patient harm, injury, complication or negative outcome that occurred because of the event.Delay in chair time due to alarms and troubleshooting required.Air in line was reported, on investigation, found that leak was present in the tubing that was within the pump chamber.A bubble of fluid was witnessed leaking from the tubing.Line required to be disconnected from patient.Approx 7-10 ml of medication lost in line that was unable to be delivered to patient.

• Brand Name: UNSPECIFIED BD INFUSION 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18647152
• MDR Text Key: 334670879
• Report Number: 9616066-2024-00184
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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: 2420-0007
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1