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

Catalog Number	10015414
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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 set was backflowing the following information was received by the initial reporter with the following verbatim: we had another blood tubing back-flow issue, involving rbcs.After the cns/cpl meeting earlier this week, and based on the recommendation from the perelman infusion nurse, i advised my nurses to make sure they clamp the free spike right above the chamber.Turns out most of my nurses do that anyway, but it was done with this transfusion and didn¿t work.Nurse ended up using hemostat to stop the rbcs from dripping.
Additional Manufacturer Narrative
It was reported that there was backflow.One photo was taken by the customer which verifies the back flow complaint.Due to no sample being returned further investigation can not be conducted.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
No additional info.

• Brand Name: BD ALARIS PUMP MODULE BLOOD 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: 19828532
• Report Number: 9616066-2024-01032
• Device Sequence Number: 20711272
• Product Code: FPA
• UDI-Device Identifier: 10885403233999
• UDI-Public: (01)10885403233999
• 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: 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: 10015414
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/30/2024
• 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