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

Model Number 10802688

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 3 bd alaris¿ infusion pumps experienced component separation.The following information was provided by the initial reporter: i have a nurse who has had some issues with the bd smartsite gravity set iv tubing coming detached from the drip chamber.She said they've had 3 instances of this over the past month.

Manufacturer Narrative

H.6.Investigation: the customer reported separation at the drip chamber, and returned one unused sample in open packaging, of material #10802688 lot #21069557.The sample was clearly separated below the drip chamber and the complaint is verified.Pictures of the sample were sent to the manufacturing for further investigation, and they found the root cause to be inconsistent use of fixture and undefined screw depth spec for dispenser.A device history record review for model 10802688 lot number 21069557 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of separation other component - no leak with lot #21069557 regarding item #10802688.

Event Description

It was reported that 3 bd alaris¿ infusion pumps experienced component separation.The following information was provided by the initial reporter: i have a nurse who has had some issues with the bd smartsite gravity set iv tubing coming detached from the drip chamber.She said they've had 3 instances of this over the past month.

• Brand Name: BD ALARIS¿ INFUSION PUMP
• Type of Device: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12674737
• MDR Text Key: 277884254
• Report Number: 9616066-2021-52277
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403234437
• UDI-Public: 50885403234437
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10802688
• Device Catalogue Number: 10802688
• Device Lot Number: 21069557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1