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

Catalog Number 2420-0007

Device Problem Improper Flow or Infusion (2954)

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

Event Date 10/07/2022

Event Type  malfunction  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Fda notified?: the initial reporter also notified the fda via medwatch # mw5114780.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the unspecified bd¿ infusion set tubing experienced flow issues during the lidocaine infusion and was running after disconnecting it from the pump.The following information was provided by the initial reporter: "during emergence phase, lidocaine tubing noted to be running wide open after disconnecting pump tubing from pump.Ce investigated unit and tested unit.Ce could not duplicate the issue and reporting findings to risk.Appears to be tubing malfunction.".

Manufacturer Narrative

The customer provided additional information, and the following fields have been updated: b.5.Describe event or problem: it was reported that the bd alaris¿ pump module smartsite¿ infusion set tubing experienced flow issues during the lidocaine infusion and was running after disconnecting it from the pump.D.1.Medical device brand name: bd alaris¿ pump module smartsite¿ infusion set.D.3.Medical device catalog #: 2420-0007.D.5.Medical device manufacturer: sistemas medicos alaris, s.A.De c.V.D.6.Unique identifier (udi) #: (b)(4).G.3.Manufacturing location: sistemas medicos alaris, s.A.De c.V.G.5.Pma / 510(k)#: k944320.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set tubing experienced flow issues during the lidocaine infusion and was running after disconnecting it from the pump.The following information was provided by the initial reporter: "during emergence phase, lidocaine tubing noted to be running wide open after disconnecting pump tubing from pump.Ce investigated unit and tested unit.Ce could not duplicate the issue and reporting findings to risk.Appears to be tubing malfunction.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 24-apr-2023.Sample was returned and tested under.No issues were found with the tubing.The customer complaint that there was unregulated flow could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review could not be performed because a lot number was not provided by the customer.H3 other text : see h10.

Event Description

It was reported that the unspecified bd¿ infusion set tubing experienced flow issues during the lidocaine infusion and was running after disconnecting it from the pump.The following information was provided by the initial reporter: "during emergence phase, lidocaine tubing noted to be running wide open after disconnecting pump tubing from pump.Ce investigated unit and tested unit.Ce could not duplicate the issue and reporting findings to risk.Appears to be tubing malfunction.".

• Brand Name: BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION 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 NJ 22244
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana NJ 22244
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16541775
• MDR Text Key: 311336127
• Report Number: 2243072-2023-00388
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 07613203021012
• 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,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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