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	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2024
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 set was occluded the following information was received by the initial reporter with the following verbatim: patient was receiving 2 units of blood (due to his 15 ml/kg hitting the max of 2 units).The second unit was running slower, over 3 hours due to discomfort in the patient's hand during transfusion.At the end of the transfusion, the chamber of the tubing had blood in the base of it and also had blood on top of the chamber but in the middle it had "run dry".Since the blood bag had been completed, i clamped and switched over to the ns flush and the chamber had back flowed into the saline bag, mixing it with blood.All throughout any attempts of running the blood or the flush, the pump would continue to say that the patient side was occluded.Due to the inability of flushing the tubing, the patient did not receive the blood left in the tubing but did receive a flush of ns following the transfusion.
Additional Manufacturer Narrative
Investigation results: it was reported that there was an occlusion and back flow.One sample model 10015414, lot 24026234 was returned for investigation by the customer.The set was examined for defects and abnormalities.No defects or abnormalities were observed.One spike was attached to am iv bag filled with water and the other spike was attached to an iv bag with blue dye water.One clamp was opened at a time and the set was able to flow.No back flow or occlusion was observed.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 10015414 lot number 24026234 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 27feb2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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.

• 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: 19914698
• Report Number: 9616066-2024-01087
• Device Sequence Number: 7208104
• Product Code: FPA
• UDI-Device Identifier: 10885403233999
• UDI-Public: (01)10885403233999(11)240227(17)270227(10)24026234
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 10/21/2024

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: 24026234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown