MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. LOW SORBING EXT SET; EXTENSION SET

Catalog Number C20350

Device Problems Free or Unrestricted Flow (2945); Infusion or Flow Problem (2964)

Patient Problem Underdose (2542)

Event Date 06/02/2020

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 low sorbing ext set experienced air in line/air bubbles and underinfusion.The following information was provided by the initial reporter: the problem we had is that it draws air down the system so that the bag does not drain on all drugs.The consequence is that the patient receives a smaller amount than they are prescribed.In some preparations, there have been so many problems with air that we have to change filters during treatment.Our feeling is that it draws air where you connect the filter to the cytostatic unit.There may be another explanation, but there will be air entering the system when the infusion has been going on for a while.

Event Description

It was reported that the low sorbing ext set experienced air in line / air bubbles and underinfusion.The following information was provided by the initial reporter: the problem we had is that it draws air down the system so that the bag does not drain on all drugs.The consequence is that the patient receives a smaller amount than they are prescribed.In some preparations, there have been so many problems with air that we have to change filters during treatment.Our feeling is that it draws air where you connect the filter to the cytostatic unit.There may be another explanation, but there will be air entering the system when the infusion has been going on for a while.

Manufacturer Narrative

H.6.Investigation summary: three c20350 samples from lot: 19105771 were received for investigation in sealed packaging.Additionally a fresenius kabi m4644400s gravity set from lot: 32493179 was received in sealed packaging to assist the investigation (appendix 1 and 2).[note all the samples were assigned to complaint: (b)(4).A visual inspection of the samples did not identify any signs of damage or manufacturing issue which could have contributed to the customer's experience.In order to replicate the set-up used by the customer as similar as possible, functional testing was performed by priming the fresenius kabi gravity set and separately connecting the male luer of each c20350 to a female luer from the "christmas tree" of the gravity set whilst water was flowing (appendix 3 and 4), then water was pushed simultaneously through the connected c20350 set with a plastipak syringe from bd stock; no ail or issues were noticed during testing.Furthermore, pressured water was applied to each c20350 sample with a plastipak syringe form bd stock; no issues or air in line was identified during testing.Additionally in the interest to test other possible configurations, the freseius kabi gravity set was primed and connected to each c20350 separately through the bottom male luer of the gravity set and continuing to prime during five minutes; no air ingress was identified at any point of the set-up during infusion.Please note the customer confirmed the set-up used by them involved various products such as fresenius iv pump and b braun sets which were not returned to assist the investigation.Root cause analysis: the alleged complaint sample was not available for investigation therefore it was not possible to confirm whether a manufacturing defect may have contributed to the reported air in line.Please note, there are a number of clinical factors that can influence the presence of air within the infusion set; the pump should be located at the level of the patient¿s heart ensuring that the tubing above the pump is straight; the infusion set should be primed slowly ensuring that all air is removed; refrigerated solutions should be allowed to reach room temperature (unless contra-indicated by the pharmacy department), and the bag should be tapped to encourage de-gassed air out of the solution.Investigation conclusion: functional testing was performed by connecting the c20350 extension sets to the needle-free connector of the fresenius kabi infusion set (appendix 3 and 4) and subjecting to an infusion; no air ingress was observed throughout testing.The c20350 extension sets were then subjected to pressure testing; no fluid leakage or air ingress was observed throughout testing.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot: 19105771 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The customer¿s experience was not confirmed in this instance.Testing of the returned samples and a review of the production records did not identify any product defects or quality deviations during assembly.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the c20350 product.

• Brand Name: LOW SORBING EXT SET
• Type of Device: EXTENSION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10224656
• MDR Text Key: 200410327
• Report Number: 9616066-2020-02084
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/17/2022
• Device Catalogue Number: C20350
• Device Lot Number: 19105771
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 20200602
• Patient Outcome(s): Other