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

Catalog Number	2278-0500
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd alaris¿ pump module non-vented blood set had air in the line after priming the platelets with blood product and starting the transfusion.The following information was provided by the initial reporter: "air in line.Platelets ordered for patient.Platelets primed with blood product tubing per protocol.Rn stayed in the room for 15 minutes doing line dressing change, and 10 minutes into transfusion air-in-line started alarming.About 12 inches of air from end of drip chamber to below module end.Infusion stopped and new blood product tubing primed.Infusion continued without issue.".
Event or Problem Description
It was reported that the bd alaris¿ pump module non-vented blood set had air in the line after priming the platelets with blood product and starting the transfusion.The following information was provided by the initial reporter: "air in line.Platelets ordered for patient.Platelets primed with blood product tubing per protocol.Rn stayed in the room for 15 minutes doing line dressing change, and 10 minutes into transfusion air-in-line started alarming.About 12 inches of air from end of drip chamber to below module end.Infusion stopped and new blood product tubing primed.Infusion continued without issue.".
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.The customer complaint that there was air in line could not be verified due to the product not being returned for failure investigation.A device history record review for model 2278-0500 lot number 22095048 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 03sep2022.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.

• Brand Name: BD ALARIS¿ PUMP MODULE NON-VENTED 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16987139
• Report Number: 9616066-2023-00990
• Device Sequence Number: 15126698
• Product Code: FPA
• UDI-Device Identifier: 10885403223266
• UDI-Public: 10885403223266
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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: Health Professional
• Device Expiration Date: 09/01/2025
• Device Catalogue Number: 2278-0500
• Device Lot Number: 22095048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown