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

Model Number	10321214
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
It was reported that an iv extension tubing broke at pressure sensing disc area while the rn was trying remove the disc from the iv infusion pump at the end of heparin infusion (heparin 50 units in 0.45% sodium chloride at 2ml/hr).There was no patient harm.
Additional Manufacturer Narrative
The customer report that the tubing broke at the pressure sensing disc area was confirmed based on the inspection of the as-received set.The customer also provided photos showing a separation at the engagement between a syringe administration set's pressure sensing disc and tubing components.The separation was observed at the engagement between the outlet of the pressure sensing disc and microbore tubing components.Inspection of the separated tubing end observed insufficient to no solvent traces and evidence that the tubing was not fully inserted into the outlet of the pressure sensing disc.Functional testing was unable to be performed on the received set due to the obvious separation.Dimensional analysis of the separated tubing end was observed to be within specification.The root cause of the noted gap is due to a combination of factors related to insufficient solvent and improper assembly due to equipment and/or operator error.
Event or Problem Description
It was reported that an iv extension tubing broke at the pressure sensing disc area while the nurse was trying remove the disc from the iv infusion pump.This occurred at the end of a heparin infusion (heparin 50 units in 0.45% sodium chloride at 2ml/hr).There was no patient harm.

• Brand Name: ALARIS SYRINGE MODULE SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9102088
• Report Number: 9616066-2019-02679
• Device Sequence Number: 3046798
• Product Code: FPA
• UDI-Device Identifier: 10885403234187
• UDI-Public: 10885403234187
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10321214
• Device Catalogue Number: 10321214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2019
• Supplement Report FDA Received Date: 09/27/2019
• 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: 8110, 8015, MICROCLAVE, TD (B)(6) 2019