MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM 20DP CKV 3SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number 2426-0007

Device Problem Backflow (1064)

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

Event Date 07/29/2021

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 gem 20dp ckv 3ss dehp free had flow issues.The following information was provided by the initial reporter: "secondary infusion attached to primary line.Smart valve defective and secondary infusion backfilled into primary fluid.".

Event Description

It was reported gem 20dp ckv 3ss dehp free had flow issues.The following information was provided by the initial reporter: "secondary infusion attached to primary line.Smart valve defective and secondary infusion backfilled into primary fluid.".

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer for this complaint.The customer complaint that the smart valve was defective and the secondary infusion backfilled into the primary could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: GEM 20DP CKV 3SS DEHP FREE
• 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: 12425816
• MDR Text Key: 269906943
• Report Number: 9616066-2021-51964
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403227996
• UDI-Public: 50885403227996
• 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: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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