MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20DP CKV 2SS 0.2MF LOW SORBING; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 11532269

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 20065925, medical device expiration date: 2023-06-09, device manufacture date: 2020-06-08.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: no product or photo was returned by the customer.The customer complaint of the tubing was found to be crooked in the pump segment which made it difficult to prime or irrigate the line could not be verified due to the product not being returned for failure investigation.A device history record review for model 11532269 lot number 20065925 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 09jun2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the gem v/nv 20dp ckv 2ss 0.2mf low sorbing experienced kinked tubing.The following information was provided by the initial reporter: material #: 11532269 , batch/ lot #: 20065925.A defect was found in the primary lines: bd alaris® pump infusion set 0.2 micron filte, which are found to be crooked in the pump segment.This event was detected today, (b)(6) 2020 when preparing a very high cost monoclonal antibody, which made it difficult to do the "priming" or irrigation of the line.

Event Description

It was reported that the gem v/nv 20dp ckv 2ss 0.2mf low sorbing experienced kinked tubing.The following information was provided by the initial reporter: material #: 11532269, batch/ lot #: 20065925.A defect was found in the primary lines: bd alaris® pump infusion set 0.2 micron filte, which are found to be crooked in the pump segment.This event was detected today, (b)(6)2020 when preparing a very high cost monoclonal antibody, which made it difficult to do the "priming" or irrigation of the line.

Manufacturer Narrative

H6: investigation summary: no product or photo was returned by the customer.The customer complaint the tubing found to be crooked in the pump segment which made it difficult to prime or irrigate the line could not be verified due to the product not being returned for failure investigation.A device history record review for model 11532269 lot number 20065925 was performed.The search showed that a total of(b)(4) in 1 lot number was built on 09jun2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h.10.

• Brand Name: GEM V/NV 20DP CKV 2SS 0.2MF LOW SORBING
• 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 22244 ; MX 22244
• MDR Report Key: 11092508
• MDR Text Key: 234296242
• Report Number: 9616066-2020-20684
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232343
• UDI-Public: 10885403232343
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 11532269
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1