MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ SECONDARY SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	11448964
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd alaris¿ secondary set backflow occurred.There was no report of patient impact.The following information was provided by the initial reporter: potential backcheck valve (bcv) failure micafungin iv hung on secondary line at approximated 0835h and programmed to run over 1 hr.At approx.0850h writer noticed that micafungin bag was completely empty but vtbi on pump still showing approx 85ml (total volume 110ml).Drip chamber of primary line completely full, but had only been 1/2 full before infusion.Infusion was stopped and iv tubing switched out for new primary + secondary tubing.Md notified and micafungin dose repeated per md.Probable failed back check valve bd alaris pump infusion set (ref # 2420-0007), bd secondary set (ref # 11448964).
Event or Problem Description
It was reported while using bd alaris¿ secondary set backflow occurred.There was no report of patient impact.The following information was provided by the initial reporter: potential backcheck valve (bcv) failure micafungin iv hung on secondary line at approximated 0835h and programmed to run over 1 hr.At approx.0850h writer noticed that micafungin bag was completely empty but vtbi on pump still showing approx 85ml (total volume 110ml).Drip chamber of primary line completely full, but had only been 1/2 full before infusion.Infusion was stopped and iv tubing switched out for new primary + secondary tubing.Md notified and micafungin dose repeated per md.Probable failed back check valve bd alaris pump infusion set (ref # (b)(6), bd secondary set (b)(6).
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 22-may-2023 h6: investigation summary one primary set (model #2420-0007) and one secondary set (model #11448964) were returned by the customer.It was reported by the customer that there was a potential backcheck valve (bcv) failure.The samples were examined for defects and abnormalities.No defects or abnormalities were observed.Functional testing was performed by using a primary bag filled with clear saline which was then used to prime the set.The secondary set was connected to a bag filled with a blue dye/water mixture, and then connected to the primary set.The sets were set up in a secondary infusion configuration with the fluid level of the secondary bag at least 9.5 inches higher than the primary bag fluid level, and all of the clamps closed.The secondary set was primed with the secondary roller clamp fully opened.Fluid flow was controlled using the primary roller clamp.Fluid was found to be flowing normally.No back flow was observed.An infusion was completed using the bd alaris pump and pump module at 125 ml/hr with a vtbi of 125 ml.Fluid was flowed into an empty beaker.After 1 hour there was about 125 m/l of saline in the beaker.Fluid was flowing normally.No back flow was observed.The failure was unable to be replicated, and the complaint could not be verified.A root cause was unable to be determined because the failure was unable to be replicated.A lot number for 2420-0007 is unknown, however, several potential lots were identified to be: 22125475, 22125497, 22125498, 22125503, 22125504, 22125523 a device history record review for model 2420-0007 and possible lot number 22125475 was performed.The search showed that a total of 51,843 units in 1 lot number was built on 20dec2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 and possible lot number 22125497 was performed.The search showed that a total of 34,563 units in 1 lot number was built on 21dec2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 and possible lot number 22125498 was performed.The search showed that a total of 51,843 units in 1 lot number was built on 21dec2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 and possible lot number 22125503 was performed.The search showed that a total of 34,563 units in 1 lot number was built on 20dec2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 and possible lot number 22125504 was performed.The search showed that a total of 17,283 units in 1 lot number was built on 12dec2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 and possible lot number 22125523 was performed.The search showed that a total of 17,283 units in 1 lot number was built on 21dec2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h10.

• Brand Name: BD ALARIS¿ SECONDARY SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16916246
• Report Number: 9616066-2023-00872
• Device Sequence Number: 2189138
• Product Code: FPA
• UDI-Device Identifier: 50885403234741
• UDI-Public: (01)50885403234741
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790582
• 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): 06/23/2023

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: 11448964
• Device Catalogue Number: 11448964
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown