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

Catalog Number	MZ9267
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter e-mail: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd maxzero microbore extension set, the device experienced a line occlusion.The following information was provided by the initial reporter.The customer stated: it was reported that a line occlusion alarm is triggered when approximately 40ml of medication or water is infused over five minutes.It was reported that in the emergency department, the syringe module alarms when using the maxzero mz9267 extension set.A ¿line occlusion¿ alarm is triggered when approximately 40ml of medication or water is infused over five minutes.If the infusion rate is slowed down, there is no longer an alarm.The information on patient involvement is unknown.Additionally, the hospital performed testing on a different pc and syringe module with a bd 50 ml syringe with water, connected and primed with a bd maxzero extension set.The syringe pump occlusion pressure limit was set to "high." and multiple tests were performed using basic infusion with infusion rates of 504 ml/hour, 480 ml/hour and 400 ml/hour.The occlusion alarm went off indicating occlusion at patient side at 504 ml/hour and at 480 ml/hour.There was no alarm at 400 ml/hour.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.It was reported that a line occlusion alarm is triggered when approximately 40ml of medication or water is infused over five minutes.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model mz9267 lot number 21105940 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 22oct2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported when using the bd maxzero microbore extension set, the device experienced a line occlusion.The following information was provided by the initial reporter.The customer stated: it was reported that a line occlusion alarm is triggered when approximately 40ml of medication or water is infused over five minutes.It was reported that in the emergency department, the syringe module alarms when using the maxzero mz9267 extension set.A ¿line occlusion¿ alarm is triggered when approximately 40ml of medication or water is infused over five minutes.If the infusion rate is slowed down, there is no longer an alarm.The information on patient involvement is unknown.Additionally, the hospital performed testing on a different pc and syringe module with a bd 50 ml syringe with water, connected and primed with a bd maxzero extension set.The syringe pump occlusion pressure limit was set to "high." and multiple tests were performed using basic infusion with infusion rates of 504 ml/hour, 480 ml/hour and 400 ml/hour.The occlusion alarm went off indicating occlusion at patient side at 504 ml/hour and at 480 ml/hour.There was no alarm at 400 ml/hour.

• Brand Name: BD MICROBORE EXTENSION SET, IV CONNECTOR
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13848340
• Report Number: 9616066-2022-00291
• Device Sequence Number: 3858349
• Product Code: FPA
• UDI-Device Identifier: 10885403240720
• UDI-Public: 10885403240720
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• 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): 03/28/2022

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 Expiration Date: 10/21/2024
• Device Catalogue Number: MZ9267
• Device Lot Number: 21105940
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 03/22/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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