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

Catalog Number 2426-0007

Device Problem Stretched (1601)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 gem 20dp ckv 3ss dehp free experienced tubing expansion/ballooning/bulging.The following information was provided by the initial reporter: material #: unknown.Batch/ lot #: unknown.Thank you for taking the time to speak with us today.When speaking about tubing, you also mentioned a ¿ballooning of the pumping segment¿.Did you happen to keep this tubing set? if so, i believe our customer advocacy group would like you to send it in.

Event Description

It was reported that the gem 20dp ckv 3ss dehp free experienced tubing expansion/ballooning/bulging.The following information was provided by the initial reporter: material #: unknown batch/ lot #: unknown thank you for taking the time to speak with us today.When speaking about tubing, you also mentioned a ¿ballooning of the pumping segment¿.Did you happen to keep this tubing set? if so, i believe our customer advocacy group would like you to send it in.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-03-12 h6: investigation summary one sample (model #2426-0007) and two photos were returned by the customer.It was reported that the tubing ballooned inside the pumping segment.The photos show the pump segment bulge.The photos verify the complaint.The returned sample was examined for defects and abnormalities.It was noticed that the tubing was returned without the drip chamber, therefore a proper infusion could not be completed.The failure was unable to be replicated.A device history record review could not be performed on model 2426-0007 because a lot number was not provided by the customer.A root cause was unable to be determined because the failure was unable to be replicated.

• 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
• MDR Report Key: 11566552
• MDR Text Key: 263606069
• Report Number: 9616066-2021-50556
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 2426-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1