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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module blood infusion set was leaking.The following information was received by the initial reporter with the following verbatim.It was reported by customer that blood dripping from the pump a few seconds after setting up the pump for blood transfusion (prbc).It was noted that the pump did not indicate any errors, and the tubing was okay during priming.It was observed that blood only started dripping after setup.
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 information.
Additional Manufacturer Narrative
It was reported by customer that blood dripping from the pump a few seconds after setting up the pump for blood transfusion (prbc).It was noted that the pump did not indicate any errors, and the tubing was okay during priming.It was observed that blood only started dripping after setup.One sample was received for quality evaluation.Visual inspection was conducted on the sample and no damages or abnormalities were identified.The sample was then primed and a leak was discovered coming from the silicone tubing of the pumping segment.Based on the findings of the investigation and the description of when the customer discovered the failure.The root cause of the leakage is determined to be a misloading of the pumping segment into the alaris pump.Leakage was not noticed during priming of the infusion set, but leakage was noticed after the tubing was set in the pump, which indicates that the set was misloaded causing for the silicone tubing of the pumping segment to become damaged.Bd clinical has been notified to determine if further instruction or training is needed for proper use of the infusion sets.A device history record review for model 2278-0500 lot number 24066739 was performed.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: 21068798
• Report Number: 9616066-2024-02173
• Device Sequence Number: 8409005
• Product Code: FPA
• UDI-Device Identifier: 10885403223266
• UDI-Public: (01)10885403223266(11)240624(17)270624(10)24066739
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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: 24066739
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown