MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD ALARIS PUMP MODULE SMARTSITE INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number 2420-0007

Device Problem Separation Failure (2547)

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

Event Date 10/28/2021

Event Type  malfunction  

Event Description

It was reported that bd alaris pump module smartsite infusion set had the components separate.The following information was provided by the initial reporter: "it was reported that when rn went to prime the line it came apart in my hands.".

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd alaris pump module smartsite infusion set had the components separate.The following information was provided by the initial reporter: "it was reported that when rn went to prime the line it came apart in my hands.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/2/2021.H.6.Investigation: one sample (model #2420-0007) was returned by the customer.It was reported that when the rn went to prime the line it came apart.The sample was examined for defects and/or abnormalities.The sample arrived separated at the upper connection of the pumping segment.The customer complaint can be verified.Visual inspection under magnification was performed on the silicon pumping segment.The silicon showed no evidence of the ring retainer being attached during assembly.Indentation from the retainer ring could not be observed, and no retainer ring was returned.A quality notification was sent to the supplier for further investigation.A dimensional test was performed on the separated components.The measurements of the components were all found to be within specification, except for the length of the pumping segment tubing.The pumping segment tubing length was found to be only about 5.2 inches, while the length should actually be 5.375 inches.A test with a silicon tube of 5.2 inches was performed to verify if the pumping chamber machine sensors work properly to create the pumping segment assembly.The machine did not detect the silicon tubing of 5.2 inches and did not activate.The pumping chamber machine sensor was working properly, therefore no assembly is performed with a 5.2 inch silicon tube.The root cause remains undetermined after further investigation.A device history record review for model 2420-0007 lot number 21096043 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 #21096043 regarding item #2420-0007.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE INFUSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12898358
• MDR Text Key: 285173442
• Report Number: 1911916-2021-01192
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021020
• UDI-Public: 37613203021020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• 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: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 21096043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• 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