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

Catalog Number	2278-0500
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module blood infusion set had air line the following information was received by the initial reporter with the following verbatim: we have created a pr 9705212 for the pump complaint.Can you assess the source mail and customer response mail and confirm if disposable complaint is needed for the same? it was reported that there was air in the lv set line.The customer replaced the iv tubing, and air was still noted.There was patient involvement and no harm.Bd received additional information.It was reported that the air bubbles were in the tubing were observed below the air-in-line sensor ("about 6 inches bubble of air") and the device did not alarm air-in-line.The tubing involved was bd alaris pump infusion blood set ref#2278-0500.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional info.
Additional Manufacturer Narrative
It was reported that there were air bubbles below the pump.One unopen sample model 2278-0500 lot: 23055146 was returned for investigation and investigated under (b)(4).From the investigation, the primary set (model 2278-0500 lot: 23055146) was removed from the original packaging and was attached directly to an iv bag of distilled water.No leaks or holes were observed.Closing each clamp individually resulted in flow stop as expected.The customer complaint was unable to be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 2278-0500 lot number 23055146 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 09may2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD ALARIS PUMP MODULE BLOOD 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18859363
• Report Number: 9616066-2024-00378
• Device Sequence Number: 3325347
• Product Code: FPA
• UDI-Device Identifier: 50885403223264
• UDI-Public: (01)50885403223264
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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: 05/05/2026
• Device Catalogue Number: 2278-0500
• Device Lot Number: 23055146
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown