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	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
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
It was reported that bd alaris pump module blood infusion set was difficult to disconnect the following information was received by the initial reporter with the following : rcc received a complaint via email.Email(s) attached.Safety report (b)(4) brief factual description tubing from prbc bag stuck in bag.Took numerous people to pull tubing out of bag.Once it was pulled out, blood bag port broke off.Unable to hang flush on the blood tubing.
Additional Manufacturer Narrative
It was reported by customer that blood bag port broke off.One photo was received for quality evaluation.Examination of the photo submitted shows that a drip chamber spike has broken away from an iv bag that was connected to.From the photo, the spike appears to be broken and the infusion bag connection has been separated from the bag assembly and is still connected to the spike.A root cause for the reported failure could not be determined because the physical product was not submitted for a complete evaluation.The probable cause for the issue is that the infusion set spike was inserted or disconnected at an angle creating a force strong enough to break the spike of the drip chamber.A device history record review could not be performed because the lot number is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• 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: 19630636
• Report Number: 9616066-2024-00951
• Device Sequence Number: 7092832
• Product Code: FPA
• UDI-Device Identifier: 10885403223266
• UDI-Public: (01)10885403223266
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: 2278-0500
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown