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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 damaged the following information was received by the initial reporter with the verbatim: during blood transfusion the nurse attempted to squeeze the non-vented drip chamber to get more blood into the chamber.However, as soon as the nurse has squeezed it, one of the tubes attached to the blood side popped off and got disconnected from the filter.Subsequently, blood free flowed from the disconnected tubing unto the floor and the nurse.
Event or Problem Description
No additional information was provided.Material#: 10015414, batch number#: 23085527.Customer response: the incident was identified after the infusion had already begun.We run the blood initially as a test dose over 15 minutes at a low rate.After the 15-minute test dose had completed, i went to check the line and squeeze more blood into the drip chamber and as soon as i touched the drip chamber the tubing disconnected from the drip chamber and blood leaked out onto the floor and onto myself.I hope this helps.
Additional Manufacturer Narrative
The customer reported the tubing snapped off, and returned one photo of material 10015414 and lot 23085527.The picture(s) were examined, and the failure was verified.The tubing was separated enough to be an issue and allow air into the line.A notification was sent to manufacturing, but without the physical sample for investigation, not enough information is available, and the root cause was unable to be found.Device history record review for model 10015414 lot number 23085527 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02sep2023.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.

• 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: 18423455
• Report Number: 9616066-2023-02452
• Device Sequence Number: 8089115
• Product Code: FPA
• UDI-Device Identifier: 50885403233997
• UDI-Public: (01)50885403233997
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K894842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2024

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 Expiration Date: 08/18/2026
• Device Catalogue Number: 10015414
• Device Lot Number: 23085527
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown