MAUDE Adverse Event Report: CAREFUSION SD ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2426-0007

Device Problems Use of Device Problem (1670); Free or Unrestricted Flow (2945)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 12/20/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 50ml b braun bag, lot: j9p651, exp: 02/21, 0.9% nacl injection, orange caps.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

It was reported that precedex was primed and programmed into pump, connected to the patient, and started the infusion at 0035.At 0054, the patient's blood pressure reading was 93/52 mmhg and the following concurrent infusions were paused: nitroglycerin, precedex, and propofol.The patient's blood was drawn for point-of-care blood analysis (i-stat) and arterial blood gas (abg).However, the patient was connected to the pacemaker at 0058, set at 92 beats per minute av paced, because the patient's heart rate was reading low at 40 beats per minute.It was then found that the precedex bag was empty at 0103.The tubing was immediately unhooked from the patient and upon opening the pump's door, the medication free flowed onto the floor despite the presence of safety clamp.

Event Description

It was reported that precedex was primed and programmed into pump, connected to the patient, and started the infusion at 0035.At 0054, the patient's blood pressure reading was 93/52 mmhg and the following concurrent infusions were paused: nitroglycerin, precedex, and propofol.The patient's blood was drawn for point-of-care blood analysis (i-stat) and arterial blood gas (abg).However, the patient was connected to the pacemaker at 0058, set at 92 beats per minute av paced, because the patient's heart rate was reading low at 40 beats per minute.It was then found that the precedex bag was empty at 0103.The tubing was immediately unhooked from the patient and upon opening the pump's door, the medication free flowed onto the floor despite the presence of safety clamp.

Manufacturer Narrative

Additional information provided: a.4.Although requested, a.1 not provided by customer.The reported issue that a bag of the drug precedex having emptied prematurely, and that the fluid had free flowed when the door was opened could not be confirmed or duplicated during the investigation physical inspection of the device noted no issues or any anomalies.Actual drug infusing on the reported source pump module could not be identified due to the programming being a drug calculation and not a selected drug from the drug library.¿the infusion was terminated after only recording infusing 0.787ml from a programmed vtbi at 35ml; however the cause for its early termination could not be ascertained from the log.¿the log had recorded 10 occurrences of the safety clamp open alarm having been generated prior to the termination of the infusion; however the cause for the alarms could not be ascertained from the log or if the roller clamp on the administration set was in a closed state.Testing of the administration set roller clamp found it to be functioning as intended.Dimensional analysis of the silicone segment section found it to be within specifications.¿rate accuracy testing and testing of the pump module sear¿s ability to properly close the safety clamp on the administration set, found the pump module to not be over infusing, having any unregulated flow during testing, or during door openings.¿an incidental finding was the pump module to be under infusing which was corrected with recalibration; this issue would not have been a contributing factor for the customer¿s reported incident.The root cause for the reported issue of finding a bag of the drug precedex having emptied prematurely, and that the fluid had free flowed when the door was opened, could not be identified.

Manufacturer Narrative

Cont¿d from d.11: 50ml b braun bag lot j9p651 exp 02/21, 0.9% nacl injection, orange caps.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Although requested, information on a1 and a4 were not provided.

Event Description

It was reported that precedex was primed and programmed into pump, connected to the patient, and started the infusion at 0035.At 0054, the patient's blood pressure reading was 93/52 mmhg and the following concurrent infusions were paused: nitroglycerin, precedex, and propofol.The patient's blood was drawn for point-of-care blood analysis (i-stat) and arterial blood gas (abg).However, the patient was connected to the pacemaker at 0058, set at 92 beats per minute av paced, because the patient's heart rate was reading low at 40 beats per minute.It was then found that the precedex bag was empty at 0103.The tubing was immediately unhooked from the patient and upon opening the pump's door, the medication free flowed onto the floor despite the presence of safety clamp.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9786099
• MDR Text Key: 184693974
• Report Number: 9616066-2020-00655
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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: (3)PRI TUBING, (4) 8100,8015, TD: (B)(6) 2019.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 122 KG