MAUDE Adverse Event Report: CFN MEXICO 215 SA DE CV 84 INCH EXT SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	C25006
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 the box of 84 inch ext set tubing units would not push propofol through them.The following information was provided by the initial reporter: "it was only reported to me that the tubing will not work as an extension set in our covid unit and not to bring any more.I do know for sure, they were unable to push the drug propofol, but when we used other tubing from bd, as an extension, we could." "the micro tubing will not push the thicker drugs through it".
Event or Problem Description
It was reported that the box of 84 inch ext set tubing units would not push propofol through them.The following information was provided by the initial reporter: "it was only reported to me that the tubing will not work as an extension set in our covid unit.And not to bring any more.I do know for sure, they were unable to push the drug propofol, but when we used other tubing from bd, as an extension, we could."."the micro tubing will not push the thicker drugs through it".
Additional Manufacturer Narrative
The customer reported that thicker drugs were not able to be pushed through the micro tubing.The customer provided the following additional information: "it just doesn't work with the alaris pumps" and "unable to push the drug propofol".The reported event microbore tubing extension set model c25006 was not received for evaluation.Received were 100 unopened microbore tubing extension sets model c25006 lot 20056369.According to clinical customer advocacy, the reported drug (propofol) has a milky consistency and its infusions are weight based.24¿48ml/hr is a typical maintenance infusion rate.Evaluation of 59 samples were performed.The sample size quantity was determined per 1701-008-000 swi sample size selection work instruction v.08 (dir 10000123008_08).Visual inspection of the set samples observed no obvious issues.Using intralipid 20% iv fat emulsion fluid to closely replicate the viscosity of the reported drug, a new primary set sample was primed with the fluid and loaded into a lab pump module device.Functional testing was performed by attaching each extension set sample to the primary set's male luer and starting an infusion with a rate of 50ml/hr.The fluid was observed to flow through each extension set and exit its luer end as expected.No alarms or issues were observed.Additional testing of infusing a few of the set samples at a slower rate of 10ml/hr also observed no alarms or issues.Equipment used (testing performed on 23sep2020): - 8100 pump module/eq103048 (calibration/pm due date 12aug2021); - 8015 pcu/eq10291 (calibration/pm due date 20mar2021).The device history record for model c25006 lot 20056369 shows the set was manufactured on 18may2020 with a total of (b)(4) units built.There were no quality notifications issued during the production build of this set.The customer's report that thicker drugs were not able to be pushed through the micro tubing was not confirmed.The root cause was not identified.

• Brand Name: 84 INCH EXT SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CFN MEXICO 215 SA DE CV; parque industrial el florido.; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10402782
• Report Number: 9616066-2020-02467
• Device Sequence Number: 19567673
• Product Code: FPA
• UDI-Device Identifier: 10885403235603
• UDI-Public: 10885403235603
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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 Expiration Date: 05/18/2023
• Device Model Number: C25006
• Device Catalogue Number: C25006
• Device Lot Number: 20056369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other