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

Model Number	C24105E
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Respiratory Distress (2045)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 100ml b braun ndc: (b)(4), lot j8j680, exp 10/2019, 5% dextrose injection; 1000ml b braun ref l6100, ndc: (b)(4), lot j8k031, exp 02/2021, 5% dextrose and 0.9% nacl; non-bd secondary set, therapy date: (b)(6) 2018.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 or Problem Description
The customer reported that the device allowed air bubbles through the air-in-line detector without alarming during a d5%ns infusion at 150ml/hr, and a secondary zofran 16mg infusion over 15 minutes.The air-in-line detection was set to 75 microliters and the accumulated air settings were enabled.Although there was no lasting injury, the patient experienced shortness of breath and the nurse practitioner was notified.The device was sequestered with the iv administration set disconnected.The biomed department tested the device on 12/21/2018 and found no discrepancies using the calibrated administration set and a calibrated dryset (asm check-in test).They also performed an air bubble detection test and no air was noted in the line.The customer would like second opinion regarding the administration set that was used on the patient because there were 2 lines connected to it, as well as the lvp unit.
Event or Problem Description
The customer reported that the device allowed air bubbles through the air-in-line detector without alarming during a d5%ns infusion at 150ml/hr, and a secondary zofran 16mg infusion over 15 minutes.The air-in-line detection was set to 75 microliters and the accumulated air settings were enabled.Although there was no lasting injury, the patient experienced shortness of breath and the nurse practitioner was notified.The device was sequestered with the iv administration set disconnected.The biomed department tested the device on (b)(6) 2018 and found no discrepancies using the calibrated administration set and a calibrated dryset (asm check-in test).They also performed an air bubble detection test and no air was noted in the line.The customer would like second opinion regarding the administration set that was used on the patient because there were 2 lines connected to it, as well as the lvp unit.
Additional Manufacturer Narrative
Cont'd from concomitant medical products: 50ml iv bag of ondansetron (zofran) 16mg in dextrose 5% 50 ml iv (b.Braun 50ml, ndc 0264-1510-31, lot number j8j680, exp 10/19).The customer¿s report that the device allowed air bubbles through the air-in-line detector without alarming during a d5%ns infusion was not confirmed.Upon visual inspection, air bubbles were observed throughout the suspect primary set tubing and attached non-bd secondary set.Functional and pressure testing resulted in the set flowing freely and showed no signs of air being introduced into the line.The sets primed completely.The root cause of the customer¿s report that the device allowed air bubbles through the air-in-line detector without alarming during a d5%ns infusion could not be determined.
Additional Manufacturer Narrative
The customer¿s report that the device allowed air bubbles through the air-in-line detector without alarming during a d5%ns infusion was confirmed but not replicated.The cad_8015 (pcu 1.5) was not returned for this investigation, therefore a review of the pcu logs could not be performed.Review of the pump module error log showed no errors or malfunctions during the reported event date of on (b)(6) 2018.The cad_8100 (system lvp) event log shows that the device was not powered on during the event time frame of on (b)(6) 2018.Therefore, no air-in-line alarms were recorded on the day of the event.However, there were multiple air-in-line alarms on (b)(6) 2018.
Event or Problem Description
The customer reported that the device allowed air bubbles through the air-in-line detector without alarming during a d5%ns infusion at 150ml/hr, and a secondary zofran 16mg infusion over 15 minutes.The air-in-line detection was set to 75 microliters and the accumulated air settings were enabled.Although there was no lasting injury, the patient experienced shortness of breath and the nurse practitioner was notified.The device was sequestered with the iv administration set disconnected.The biomed department tested the device on 12/21/2018 and found no discrepancies using the calibrated administration set and a calibrated dryset (asm check-in test).They also performed an air bubble detection test and no air was noted in the line.The customer would like second opinion regarding the administration set that was used on the patient because there were 2 lines connected to it, as well as the lvp unit.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8274213
• Report Number: 9616066-2019-00142
• Device Sequence Number: 19236687
• Product Code: FPA
• UDI-Device Identifier: 07613203019040
• UDI-Public: 7613203019040
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C24105E
• Device Catalogue Number: C24105E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 02/25/2019; 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015,(2)8100,PRI TUBING, THERAPY DATE 12/11/18; GREEN END CAP; 8015,(2)8100,PRI TUBING, THERAPY DATE: (B)(6) 2018
• Outcome Attributed to Adverse Event: Other