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

Catalog Number	10062818
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
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 damaged the following information was received by the initial reporter with the following verbatim: brief factual description: "target: our blood tubing should be a closed system that fluid/blood should not be able to escape from.Actual: when we primed and hung blood tubing, we clamped the lines above the buretrol before we connected the tubing to the patient.When we brought the blood over to the alaris pump, we noticed a few drops of blood that had fallen onto the pump.We discovered the source of the leak appears to be that one of the clamps sliced into the blood tubing.Gap: supply failure; tubing was unable to be clamped while remaining intact.".
Additional Manufacturer Narrative
The customer reported leak above the pump, and returned one used sample of material 10062818, and lot unknown.The set was visually examined for defects and abnormalities.No defects or abnormalities were observed.The set was infused with water, and the leak in the tubing near the drip chamber in one side of blood tubing spike.The tubing had a small cut in the tubing that caused the leak.A device history record review could not be performed on material 10062818 because the lot number is unknown.The manufacturing site conducted a further investigation on the tubing cut but could not find a root cause.The root cause for the issue is unknown and is not found to be related to the manufacturing process.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
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: 18752162
• Report Number: 9616066-2024-00282
• Device Sequence Number: 6280521
• Product Code: FPA
• UDI-Device Identifier: 07613203019668
• UDI-Public: (01)07613203019668
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 06/21/2024

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: 10062818
• Device Lot Number: UNKNOWN
• 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: 01/31/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 06/24/2024
• 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