MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT SET .2 MF LOW SORB; INTRAVASCULAR ADMINISTRATION SET

Model Number 10013902

Device Problems Break (1069); Crack (1135)

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

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.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 ext set.2 mf low sorb experienced device damage while still considered operable.The following information was provided by the initial reporter: filter cracked.

Manufacturer Narrative

H.6.Investigation: two samples were received for quality investigation.The customer complaint of component damage - leak was verified by investigation.The samples were first visually evaluated for any cracks or damages to the components of the assembly.There were no clearly apparent cracks or damages to the assembly.The samples were then tested for leaks by attaching a syringe to the extension set and pushing water through each set.Leakage was instantly noted through the vents on each of the infusion sets.A device history record review could not be performed on model 10013902 because a lot number was not provided by the customer.The root cause for the issue seen in this complaint is that the filter vents were wetted out during usage causing the filters to leak.The filters were sent to the manufacturer for investigation and the investigation did not reveal any issues with the filter itself, however, both filters showed discolored membrane and it is most likely that the fluids used by the customer caused the vent membranes to become saturated creating the leakage.

Event Description

It was reported that the ext set.2 mf low sorb experienced device damage while still considered operable.The following information was provided by the initial reporter: filter cracked.

• Brand Name: EXT SET .2 MF LOW SORB
• 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: 12367969
• MDR Text Key: 268218069
• Report Number: 9616066-2021-51894
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403233812
• UDI-Public: 50885403233812
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• 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: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10013902
• Device Catalogue Number: 10013902
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• 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