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

Model Number	10012144
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional 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.(b)(4).
Event or Problem Description
It was reported that the gem 20dp v/nv ckv 3ss experienced kinked tubing and was clogged/blocked.The following information was provided by the initial reporter: material no: 10012144 batch no: (an invalid lot # was provided as 20016683) we had an alaris tubing incident yesterday.The tubing was kinked below the drip chamber so fluid would not flow into the tubing, no matter what they tried.
Event or Problem Description
It was reported that the gem 20dp v/nv ckv 3ss experienced kinked tubing and was clogged/blocked.The following information was provided by the initial reporter: material no: 10012144 batch no: (an invalid lot # was provided as 20016683) we had an alaris tubing incident yesterday.The tubing was kinked below the drip chamber so fluid would not flow into the tubing, no matter what they tried.
Additional Manufacturer Narrative
Investigation: one sample of model 10012144 infusion set was received for quality investigation.The customer complaint of kinked tubing was verified by visual inspection.No further defects or damages were observed upon visual inspection of the tubing.A device history record review could not be performed on model 1001214 because a lot number was not provided by the customer.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Previous investigations have indicated the root cause for this issue is an incorrect assembly method of the set being coiled and pouched prior to solvent fully drying.

• Brand Name: GEM 20DP V/NV CKV 3SS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 10703499
• Report Number: 9616066-2020-20109
• Device Sequence Number: 4135194
• Product Code: FPA
• UDI-Device Identifier: 37613203021167
• UDI-Public: 37613203021167
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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
• Operator of Device: Other
• Device Model Number: 10012144
• Device Catalogue Number: 10012144
• Device Lot Number: UNKONWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1