MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ9265
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxzero multi-fuse extension set with needleless connector was under infusing the following information was received by the initial reporter with the following verbatim: 2) maxzero slows down the medication flow rate.If the medication is given without maxzero, the flow rate is quite fast, while at the same setting the medication flow rate given with maxzero is quite slow.This also happens with bolus medication.The syringes encounter resistance.While the medication was being administered by infusion pump, the pump continuously alarmed for obstruction.Although the port catheter was not occlude, the pump continued to alarm.The medication therefore took 2,5 hours to reach the patient.
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Additional information noted in adverse event or prod prob (b).Investigation result: two mz9265 samples were received for investigation, one in opened packaging and one in sealed packaging; both samples were received from lot 22109362.Additionally two ttt 10ml syringes, and one bd discardit ii 309110 syringe from lot 2110204 were also received; one of the ttt syringes, as well as the bd discardit ii syringe were received in opened packaging, whilst the second ttt syringe was received in sealed packaging.The returned samples were subjected to functional testing using a bd syringe; no occlusion was observed from either extension set throughout testing.Furthermore although resistance was experienced during a flush-through, this was determined to be due to the micro-bore tubing used within this extension set.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects or quality deviation that could have contributed to the customer¿s experience.A review of the production records for lot 22109362 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Please note, the smaller bore of the tubing means that a higher resistance is placed upon the fluid during infusion, this can translate into an increased force being required to manually prime or inject into the infusion line; therefore it may be necessary to increase the occlusion alarm threshold on the pump in order to prevent false occlusion alarms.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the mz9265 product.
Event or Problem Description
Additional information: please confirm the make and model of the connecting product(s)? ttt world disposable sterile 10 ml syringe and bd discardit ii 10 ml syringe.Please confirm the infusion set-up ¿ gravity or pump, height of infusion line, entry point to patient, infusion rate and pressure, infusion line set-up (other extensions or accessories) etc? 50-60 cm high from entry point, the infusion line is full open for gravity, 50-100 cc / hour for infusion pumps.It alarms for this infusion rates with pumps.Please confirm the number of products affected? (b)(4).Please confirm if there is any visible damage on the set ¿ such as cracks, flashes or deformation of the piston? there was no damage on the set ¿ such as cracks, flashes or deformation of the piston.Please confirm what substance was being infused during the time of the event? saline flushing solution with syringes, tazocine(antibiotic), parol (painkiller), klacide (antibiotic), blood transfusion.Please confirm when the fault was identified during priming or during infusion? if during infusion, how long into the infusion? maxzero slows down the flow rate while during infusion.It took 2.5 hours for klacide (antibiotic).Please confirm what is meant by the incompatibility between the maxzero and the syringe? was there a disconnection, leakage, occlusion or other issue? the syringes are not fixed to the maxzero hub/entry point, maxzero is pushing the luer side of syringes so the syringes don't enter the maxzero.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19824500
• Report Number: 9616066-2024-01031
• Device Sequence Number: 21055611
• Product Code: FPA
• UDI-Device Identifier: 10885403240775
• UDI-Public: (01)10885403240775
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2024

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
• Operator of Device: Other
• Device Expiration Date: 10/20/2025
• Device Catalogue Number: MZ9265
• Device Lot Number: 22109362
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown