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

Catalog Number	72215N
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No samples were received for investigation of (b )(4), in which the customer has stated: " even when using 2 hangers to lower primary line the primary line was still infusing concurrently with secondary.This resulted in longer infusion time for ivig." the product in use at the time is reported to be a 72215n from lot 24033021.Further information from the customer has stated that the reported defect was identified during the whole infusion of primary line with 0.9% sodium chloride and secondary line with ivig when the secondary line was connected with (b)(4) primary set at the flow rate of 40ml/h to approx.120ml/h.Customer has confirmed that no leakage was noticed and air vent was opened after the glass bottle was spiked and drip chamber filled.Furthermore, customer has confirmed that no physical damage or deformity was observed at the point of under infusion to the individual set packaging or the outer box when it was received in.The details of this feedback were forwarded to the manufacturing site for investigation, where a review of the production records for lot 24033021 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.The root cause of the customer¿s experience could not be determined in this instance as no sample was received for investigation.Without a sample to examine it is not possible to determine whether a manufacturing defect could have caused or contributed to a report of this nature.
Event or Problem Description
It was reported that bd alaris secondary set was under infusing the following information was received by the initial reporter with the following verbatim secondary set 72215n used to infuse ivig on 3 patients.Even when using 2 hangers to lower primary line the primary line was still infusing concurrently with secondary.This resulted in longer infusion time for ivig.This occured during infusion rates ranging from 43ml/h 180ml/h.

• Brand Name: BD ALARIS SECONDARY 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20853461
• Report Number: 9616066-2024-01873
• Device Sequence Number: 3730396
• Product Code: FPA
• UDI-Device Identifier: 10885403235467
• UDI-Public: (01)10885403235467(11)240301(17)270301(10)24033021
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022209
• 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
• Report Date (Section B): 11/19/2024

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 Catalogue Number: 72215N
• Device Lot Number: 24033021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown