MAUDE Adverse Event Report: ALS SET DC 20DP 3SS CKVLV LOW SRB DEHP F; INTRAVASCULAR ADMINISTRATION SET

Model Number	24600-0007
Medical Device Problem Codes	Leak/Splash (1354); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that als set dc 20dp 3ss ckvlv low srb dehp f experienced an air in line alarm during use, and leakage.The following information was provided by the initial reporter: we had a tubing malfunction (6/18) on our oncology unit.They removed from pump to purge with ¿air in line alarm¿ and it started leaking at the pump section tubing and that blue connector piece above the pump.
Additional Manufacturer Narrative
H6: investigation summary : the customer reported the pump alarmed "air in line" and the tubing was leaking.One used sample of material #24600-0007 was returned for investigation.The complaints of air-in-line and leakage were both verified through a couple small openings near the upper fitment on the silicon tubing.There were two openings, and appeared to be cuts or slices.No other failure modes were observed.A device history record review for model 24600-0007 lot number 21015596 was performed.The search showed that a total of 11,523 units in 1 lot number was built on 13jan2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the cuts cannot be determined at this time.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that als set dc 20dp 3ss ckvlv low srb dehp f experienced an air in line alarm during use, and leakage.The following information was provided by the initial reporter: we had a tubing malfunction (6/18) on our oncology unit.They removed from pump to purge with ¿air in line alarm¿ and it started leaking at the pump section tubing and that blue connector piece above the pump.

• Brand Name: ALS SET DC 20DP 3SS CKVLV LOW SRB DEHP F
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12186156
• Report Number: 9616066-2021-51548
• Device Sequence Number: 11013197
• Product Code: FPA
• UDI-Device Identifier: 50885403241978
• UDI-Public: 50885403241978
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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
• Operator of Device: Other
• Device Model Number: 24600-0007
• Device Catalogue Number: 24600-0007
• Device Lot Number: 21015596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 07/17/2021
• Supplement Report FDA Received Date: 08/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1