MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D LOW SORB SS 0.2M; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 10010454-0006

Device Problem Leak/Splash (1354)

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Medical 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 two as lvp 20d low sorb ss 0.2m was damaged or deformed, causing leakage.The following information was provided by the initial reporter: "set was leaking at the point where it is inserted into pump.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10/21/2021.H.6.Investigation: the customer reported leaking near the pump, and returned one used sample of material 10010454-0006.The sample was primed with blue dye water and was found to be leaking from a small hole in the silicon pumping segment.The complaint of leakage is verified.The silicon still had the ring retaining collar and was not separated, and the tubing appeared to have been stretched around the hole.The root cause is determined to be user when loading the pump segment.There is a known failure mode for improper loading of the pumping segment, we strongly recommend loading the top blue clip into the pump first and then the bottom.A device history record review for model 10010454 lot number 20095218 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 leakage with lot #20095218 regarding item #10010454-0006.

Event Description

It was reported two as lvp 20d low sorb ss 0.2m was damaged or deformed, causing leakage.The following information was provided by the initial reporter: "set was leaking at the point where it is inserted into pump.".

• Brand Name: AS LVP 20D LOW SORB SS 0.2M
• 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: 12653170
• MDR Text Key: 277137751
• Report Number: 9616066-2021-52256
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10010454-0006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2021
• 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
• Treatment: 2432-0007 AS LVP 20D 3SS 0.2M CV; 2432-0007 AS LVP 20D 3SS 0.2M CV