MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 17 INCH EXT SET W/.2MF & VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Model Number 20350E

Device Problem Leak/Splash (1354)

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

Event Date 09/09/2021

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 when using the 17 inch ext set w/.2mf & vlv port there were leaks.The following information was provided by the initial reporter.The customer stated: there was "moisture along the tpn tubing and specifically with drops of fluid coming from the flat filter piece.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-10-11.Investigation summary the customer reported that there was liquid along the filter, after infusing tpn.One sample of material #20350e was returned used.The sample was primed with water, and was found to leak from the air vent membrane.The probable root cause is use of tpn past the filter's functional duration.The vent's hydrophobic properties may become temporarily compromised or weakened from treatments and exposures that occur after filter assembly.This may result in fluid leakage through the vent, particularly with lower surface tension fluids that may contain elements of alcohol or lipids.A device history record review could not be performed on model 20350e because the lot number is unknown.

Event Description

It was reported when using the 17 inch ext set w/.2mf & vlv port there were leaks.The following information was provided by the initial reporter.The customer stated: there was "moisture along the tpn tubing and specifically with drops of fluid coming from the flat filter piece.".

• Brand Name: 17 INCH EXT SET W/.2MF & VLV PORT
• 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: 12660992
• MDR Text Key: 277375757
• Report Number: 9616066-2021-52265
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012264
• UDI-Public: 37613203012264
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

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 Model Number: 20350E
• Device Catalogue Number: 20350E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2021
• 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