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

Model Number	11607704
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris infusion set experienced tubing expansion.The following information was provided by the initial reporter: iv pump was alarming, saying the clamp was not closed after trying to push iv zofran through the patient's primary iv tubing and meeting some resistance.Opened clamp to discover the primary tubing had a large liquid bubble m the section of the tubing that claps into the channel of the iv pump.Tubing was changed at this time without any further problems.
Additional Manufacturer Narrative
Date of birth: only the patient's age was provided, therefore a default date of birth has been listed.Device expiration date: unknown.Fda notified: the initial reporter also notified the fda via medwatch (b)(4).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.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.It was reported that the tubing had a large liquid bubble in the section of the tubing that claps into the channel of the iv pump.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 11607704 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h10.
Event or Problem Description
It was reported that the bd alaris infusion set experienced tubing expansion.The following information was provided by the initial reporter: iv pump was alarming , saying the clamp was not closed after trying to push iv zofran through the patient's primary iv tubing and meeting some resistance.Opened clamp to discover the primary tubing had a large liquid bubble m the section of the tubing that claps into the channel of the iv pump.Tubing was changed at this time without any further problems.

• Brand Name: BD ALARIS INFUSION SET
• Common Device Name: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12738626
• Report Number: 9616066-2021-52353
• Device Sequence Number: 17280824
• Product Code: FPA
• UDI-Device Identifier: 50885403228009
• UDI-Public: 50885403228009
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 11/03/2021

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: Other
• Device Model Number: 11607704
• Device Catalogue Number: 11607704
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 81 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White