MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE GRAVITY BLOOD SET; INTRAVASCULAR ADMINISTRATION SET

Model Number 10010903

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 01/17/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using bd alaris smartsite gravity blood set the tubing was kinked and restricted the flow.There was no report of patient impact.The following information was provided by the initial reporter: material #: 10010903.Batch #: unknown.It was reported by the customer that the tubing kinked.

Manufacturer Narrative

H.6.Investigation: a complaint of tubing kinking during use was received from the customer.Three photos were provided by the customer.In the photos kinking during use can be seen in the tubing.There is one near the roller clamp and the other is below the drip chamber.The customer complaint was confirmed.A device history record review could not be performed on model 10010903 because the lot number is unknown.A root cause could not be determined as a physical sample was not returned for investigation.

Event Description

It was reported while using bd alaris smartsite gravity blood set the tubing was kinked and restricted the flow.There was no report of patient impact.The following information was provided by the initial reporter: material #: 10010903, batch #: unknown.It was reported by the customer that the tubing kinked.

• Brand Name: BD ALARIS SMARTSITE GRAVITY BLOOD SET
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13548479
• MDR Text Key: 285812901
• Report Number: 9616066-2022-00138
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203020879
• UDI-Public: 07613203020879
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882302
• 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: 02/17/2022

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
• Device Operator: Health Professional
• Device Model Number: 10010903
• Device Catalogue Number: 10010903
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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