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

Catalog Number 2426-0007

Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284); Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the gem 20dp ckv 3ss dehp free experienced a missing component: end cap.The following information was provided by the initial reporter: we have a batch of defective tubing 2426-0007.The y site below the back check valve is missing.Staff have tossed at least 6 sets since they can¿t attach the short set.Lot is (10)20046950.

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 07/14/2020.Investigation conclusion: it was reported that customer ordered material from model: 2426-0007 and received a set of the model: 2420-0007 inside of 2426-0007 pouch, with lot number: 20046950.Customer complaint was confirmed through pictures provided by the customer and confirmation of the sample by cad sd.After a mapping process was performed and the review of the timeline, the potential root cause identified for this failure mode is material mixed in rework of packaging.The model: 2426-0007 was built in the line 27 and the model: 2420-0007 in the line 28.In this time the conveyors of the lines did not have guards in the connection between conveyors.Guards were placed on conveyors on june 23rd, 2020 to avoid mixed of material between lines near (b)(4), although on the shore of each side of conveyor has not guards implemented then sometimes the sets could fall from conveyors to floor and the material handler must place the set inside another pouch and made it easier for the material to be mixed.The guards on the shore of each side of the conveyors will be implemented on september 23rd, 2020 by the production / process engineer, to prevent the parts falling from the conveyors and avoid carry out reworks during the production process.A device history record review for model: 2426-0007, lot number: 20046950 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 29april2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

Event Description

It was reported that the gem 20dp ckv 3ss dehp free experienced a missing component: end cap.The following information was provided by the initial reporter: we have a batch of defective tubing 2426-0007.The y site below the back check valve is missing.Staff have tossed at least 6 sets since they can't attach the short set.Lot is (10)20046950.

• Brand Name: GEM 20DP CKV 3SS DEHP FREE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10335768
• MDR Text Key: 202216137
• Report Number: 9616066-2020-02329
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

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
• Device Operator: Other
• Device Expiration Date: 04/29/2023
• Device Catalogue Number: 2426-0007
• Device Lot Number: 20046950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 20200707; 20200707
• Patient Outcome(s): Other