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

Model Number PRI TUBING

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Venipuncture (2129)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

Additional info: level after the event 3.5 ekg k+ level after the event 3.5 ekg.Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.

Event Description

It was reported there was a potassium over infusion event; the potassium appeared to be infusing too quickly.A primary infusion of potassium (kcl) 10meq in 100 ml was initiated, however the nurse noted 60ml had already infused several minutes after the start of the infusion.The patient required ekg (no changes), a repeat potassium level (normal range) and continuous monitoring (no changes noted).No lasting harm was reported.Although requested there were no further details of the event received.Received a copy of the customer medwatch report of (b)(6) 2019 that stated:"10meq/100ml potassium chloride started at 0659.Rn stayed with patient as drip started.At 0710, bag "seemed too empty for time hanging".Channel off button pressed.After stopping the pump to stop potassium from infusing, the potassium continued to slowly infuse.Roller camp on tubing had to be closed and patient was unhooked from iv immediately".

Event Description

It was reported there was a potassium over infusion event; the potassium appeared to be infusing too quickly.A primary infusion of potassium (kcl) 10meq in 100 ml was initiated, however the nurse noted 60ml had already infused several minutes after the start of the infusion.The patient required ekg (no changes), a repeat potassium level (normal range) and continuous monitoring (no changes noted).No lasting harm was reported.Although requested there were no further details of the event received.Received a copy of the customer medwatch report of 6-27-2019 that stated:"10meq/100ml potassium chloride started at 0659.Rn stayed with patient as drip started.At 0710, bag "seemed too empty for time hanging".Channel off button pressed.After stopping the pump to stop potassium from infusing, the potassium continued to slowly infuse.Roller camp on tubing had to be closed and patient was unhooked from iv immediately.".

Manufacturer Narrative

Additional info: the suspect has been changed from a disposable set to an instrument.Please reference the new manufacturer number 2016493-2019-00905 from e-mdr: (b)(4).

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8762064
• MDR Text Key: 150120856
• Report Number: 9616066-2019-01785
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRI TUBING
• Device Catalogue Number: PRI TUBING
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, TD (B)(6) 2019
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 77