MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number AZC9697

Device Problems Break (1069); Filling Problem (1233)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Event Description

It was reported that during patient infusion of fentanyl with a colleague infusion pump and solution administration set, the patient experienced severe hypotension.It was further reported the ¿set is damaged¿ and this contributed to the pump infusing faster than programmed resulting in the hypotension.The fentanyl was discontinued, and the set was changed, reportedly ¿the infusion occurred normally according to programmed¿.Subsequently, the patient was administered flumazenil and naloxone and the patient recovered from the event.No additional information is available.

Manufacturer Narrative

The event occurred on an unspecified date in 2022.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A tightness and flow testing were performed with no issues noted.The reported condition was not verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SOLUTION ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SAO PAULO; av. alfredo egidio de souza; aranha, 100, bloco c; sao paulo 47261 70; BR 4726170
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15564121
• MDR Text Key: 301368781
• Report Number: 1416980-2022-05379
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05413765414954
• UDI-Public: (01)05413765414954
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AZC9697
• Device Lot Number: PE88F9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COLLEAGUE PUMP; FENTANYL
• Patient Outcome(s): Required Intervention