MAUDE Adverse Event Report: BECTON DICKINSON BD ALARIS PUMP MODULE SMARTSITE TEXIUM; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	24601-B007T
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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)(6) has been listed.And the franklin lakes fda registration number has been used for the manufacture report number.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 or Problem Description
It was reported that the unspecified bd¿ infusion set tubing expanded during the chemotherapy infusion.The following information was provided by the initial reporter: "it was reported that the "infusion set stopped infusing".Upon inspection, clinician noticed a bulge in the tubing and pump was alarming occluded.New tubing and pump were sequestered, and infusion finished without further incident.There was patient involvement and no harm.Do you know how long the set had been in use before the bulge was discovered? it was running for 12 hours when this happened.Had an iv push been delivered prior to the bulge being discovered? yes.Can you please provide procedure involved and described medication used infusing chemotherapy".
Event or Problem Description
It was reported that the bd alaris pump module smartsite texium tubing expanded during the chemotherapy infusion.The following information was provided by the initial reporter: "it was reported that the "infusion set stopped infusing".Upon inspection, clinician noticed a bulge in the tubing and pump was alarming occluded.New tubing and pump were sequestered, and infusion finished without further incident.There was patient involvement and no harm.Do you know how long the set had been in use before the bulge was discovered? it was running for 12 hours when this happened.Had an iv push been delivered prior to the bulge being discovered? yes.Can you please provide procedure involved and described medication used - infusing chemotherapy.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 01-jun-2023.H6: investigation summary one sample (model #24601-b007t) was returned by the customer.It was reported by customer that the "infusion set stopped infusing", clinician noticed a bulge in the tubing and pump was alarming occluded.The returned set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was successfully primed.The set was infused with the bd alaris pump and pump module at 125 ml/hr with a vtbi of 125 ml.No bulging was observed in the tubing throughout the infusion and after the infusion.The failure was unable to be replicated, and the complaint could not be verified.A root cause was unable to be determined because the failure was unable to be replicated.A lot number is unknown, however, possible lot numbers were identified to be: 22085199, 22105077.A device history record review for model 24601-b007t and possible lot number 22085199 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 30aug2022.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 24601-b007t and possible lot number 22105077 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10oct2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported that the bd alaris pump module smartsite texium tubing expanded during the chemotherapy infusion.The following information was provided by the initial reporter: "it was reported that the "infusion set stopped infusing".Upon inspection, clinician noticed a bulge in the tubing and pump was alarming occluded.New tubing and pump were sequestered, and infusion finished without further incident.There was patient involvement and no harm.Do you know how long the set had been in use before the bulge was discovered? it was running for 12 hours when this happened.Had an iv push been delivered prior to the bulge being discovered? yes.Can you please provide procedure involved and described medication used : infusing chemotherapy".
Additional Manufacturer Narrative
The following fields were updated due to additional information: b5: describe event or problem: it was reported that the bd alaris pump module smartsite texium tubing expanded during the chemotherapy infusion.The following information was provided by the initial reporter: "it was reported that the "infusion set stopped infusing".Upon inspection, clinician noticed a bulge in the tubing and pump was alarming occluded.New tubing and pump were sequestered, and infusion finished without further incident.There was patient involvement and no harm.Do you know how long the set had been in use before the bulge was discovered? it was running for 12 hours when this happened.Had an iv push been delivered prior to the bulge being discovered? yes.Can you please provide procedure involved and described medication used - infusing chemotherapy".D1: medical device brand name: bd alaris pump module smartsite texium.D4: udi #: (b)(4).D4: medical device catalog #: 24601-b007t.G.5.Pma / 510(k)#: k944320.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE TEXIUM
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16464903
• Report Number: 2243072-2023-00281
• Device Sequence Number: 7671418
• Product Code: FPA
• UDI-Device Identifier: 10885403240959
• UDI-Public: 10885403240959
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 24601-B007T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 02/03/2023; 06/26/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 06/22/2023; 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown