MAUDE Adverse Event Report: CAREFUSION BD PUMP MODULE; PUMP, INFUSION

Model Number 8100

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Burning Sensation (2146); No Consequences Or Impact To Patient (2199)

Event Date 12/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Concomitant medical products: 50ml kabi bag, lot: 12ndu22, exp: 04-2021.Magnesium sulfate 2g in water for injection.1000ml baxter bag, lot: y310474, exp: dec20.0.9% sodium chloride injection.(2) curos caps.The affected device 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 a primary infusion of magnesium (2 gm./50ml) was initiated at 08:55 programmed at a rate 25ml/hr.To infuse for over 2hrs.However at 0900 the device alarmed for air-in-line, the rn noticed that the entire bag was emptied.Although the patient experienced a burning sensation to iv access there was no medical interventions or labs required.The customer confirmed that the 2nd lvp module was infusing saline at an unspecified rate.

Event Description

It was reported that a primary infusion of magnesium (2gm/50ml) was initiated at 08:55 programmed at a rate 25ml/hr.To infuse for over 2hrs., however; at 0900 the device alarmed for air-in-line, the nurse noticed that the entire bag was emptied.Although the patient experienced a burning sensation to the iv access, it was confirmed that there was no patient harm, medical intervention or labs required.The customer confirmed that the 2nd lvp module was infusing saline at an unspecified rate.

Manufacturer Narrative

The customer¿s report of an over infusion of magnesium was not confirmed.Physical inspection noted the device to be in good condition with the instrument seal intact.No anomalies were observed.Review of the pcu error log showed no errors.Log analysis of the pcu event log showed, prior to the reported event date, the pcu was powered on (b)(6) 2019 at 1:25 am and same patient and same profile ((b)(6)) were selected.On (b)(6) 2019 at 8:26 am, the suspect device (sn (b)(6)) was added to the pcu and alarmed for flo stop open.At 8:27 am, the suspect device (sn (b)(6)) was selected and programmed guardrail drug magnesium sulfate (drugid=355) at a rate of 25 ml/hr (vtbi= 50 ml).At 8:28 am, the suspect device (sn (b)(6)) alarmed for air in line and was restarted less than one minute later.At 8:30 am, the suspect device (sn (b)(6)) alarmed for air in line the flo stop open before being paused.At 8:35 am, the suspect device (sn (b)(6)) was channeled off.At 8:37 am, the suspect device (sn (b)(6)) was removed.At 8:59 am, the suspect device (sn (b)(6)) added and programmed guardrail drug magnesium sulfate (drugid=355) at a rate of 25 ml/hr (vtbi= 50 ml).At 9:00 am, the suspect device (sn (b)(6)) was channeled off.Total volume infused 8:26 am to 9:00 am= 0.72 ml.Rate accuracy testing performed found the device operating in specification.The root cause of the customer¿s report of an over infusion of magnesium was not identified.

• Brand Name: BD PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9587734
• MDR Text Key: 180555902
• Report Number: 2016493-2020-00089
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: 10885403810015
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100; 8100,8015,(2)2426-0500, TD (B)(6) 2019
• Patient Age: 68 YR
• Patient Weight: 74