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

Model Number	42493E
Medical Device Problem Codes	Failure to Prime (1492); Improper Flow or Infusion (2954); No Flow (2991)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: csc product claims coordinator inventory management.Concomitant medical products; pressure bag, iv flush syringe, therapy date unk.Patient demographics requested however not provided.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
It was reported that a patient was in cardiac arrest, a placement of an io (intraosseous infusion) catheter was inserted.The paramedics attempted to prime the tubing however fluid did not pass easily through the check valve.The tubing was able to be primed after extra pressure applied from a pressure bag but unable to flow.A flush was placed on the port just below the check valve to troubleshoot where the location of the blockage and the tubing was able to be flushed easily past the check valve however would not flow.The paramedics assumed that the io was to blame initially and placed a second io with adequate placement.When the user did not get adequate flow through the primary tubing, a second tubing was attached and flow was uninhibited.There was no lasting harm reported to the patient.
Additional Manufacturer Narrative
The customer¿s report that fluid did not pass easily through the check valve was confirmed.Visual inspection of the set noted that the check valve had been assembled into the set upside down.There were no other anomalies observed.Functional testing resulted in the set not flowing due to the misassembled upside down check valve.The root cause of the occlusion was due to the check valve being assembled into the set upside down.The root cause of the misassembly was due to an error during the manufacturing process.
Event or Problem Description
It was reported that a patient was in cardiac arrest, a placement of an io (interosseous) catheter was inserted.The paramedics attempted to prime the tubing however fluid did not pass easily through the check valve.The tubing was able to be primed after extra pressure applied from a pressure bag but unable to flow.A flush was placed on the port just below the check valve to troubleshoot where the location of the blockage and the tubing was able to be flushed easily past the check valve however would not flow.The paramedics assumed that the io was to blame initially and placed a second io with adequate placement.When the user did not get adequate flow through the primary tubing, a second tubing was attached and flow was uninhibited.There was no lasting harm reported to the patient.

• Brand Name: ALARIS GRAVITY SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8456186
• Report Number: 9616066-2019-00759
• Device Sequence Number: 14175051
• Product Code: FPA
• UDI-Device Identifier: 10885403235375
• UDI-Public: 10885403235375
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2019

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 Expiration Date: 10/29/2021
• Device Model Number: 42493E
• Device Catalogue Number: 42493E
• Device Lot Number: 18106869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/29/2019
• 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: 42493E,(2)IO CATHETER, THERAPY DATE UNK.; 42493E,(2)IO CATHETER, THERAPY DATE UNK
• Outcome Attributed to Adverse Event: Required Intervention