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

Catalog Number	MS3500-15
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2.Patient¿s birthday was not provided, (b)(6) xxxx was used based on age of patient.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris secondary set was occluded the following information was received by the initial reporter with the following verbatim: we have had multiple issues with this secondary tubing not infusing medications.This medication started dripping in the chamber when the registered nurse (rn) started the medication, but when rn returned it had stopped infusing, and the iv pump was pulling from primary fluid bag.Usually this issue is with glass vials, but this event was with a medication bag.There are extensive instructions for priming this tubing, and rn says all steps were followed appropriately.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of flow issues - fluid blockage could not be verified due to the product not being returned for failure investigation.A device history record review for material# ms3500-15 and lot# 24033261 was performed.The search showed that a total of 24,053 units in 1 lot number was built on 14mar2024.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
Material#: ms3500-15 batch#: 24033261 it was reported by the customer that we have had multiple issues with this secondary tubing not infusing medications.This medication started dripping in the chamber when the registered nurse (rn) started the medication, but when rn returned it had stopped infusing, and the iv pump was pulling from primary fluid bag.Usually this issue is with glass vials, but this event was with a medication bag.There are extensive instructions for priming this tubing, and rn says all steps were followed appropriately.Verbatim: rcc received a complaint via email.Email(s) attached.We have had multiple issues with this secondary tubing not infusing medications.This medication started dripping in the chamber when the registered nurse (rn) started the medication, but when rn returned it had stopped infusing, and the iv pump was pulling from primary fluid bag.Usually this issue is with glass vials, but this event was with a medication bag.There are extensive instructions for priming this tubing, and rn says all steps were followed appropriately.

• 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: 20541634
• Report Number: 9616066-2024-01554
• Device Sequence Number: 20830197
• Product Code: FPA
• UDI-Device Identifier: 50885403222618
• UDI-Public: (01)50885403222618(11)240314(17)270314(10)24033261
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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: MS3500-15
• Device Lot Number: 24033261
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 10/27/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Sex: Male
• Patient Weight: 68 KG