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

Model Number	MS3500
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.Race: caucasian.Medical history: metastatic testicular carcinoma, admitted for chemotherapy.
Event or Problem Description
It was reported that the rn spiked the bag of iv potassium iv piggyback using secondary tubing and the tubing came apart below the drip chamber.The event occurred prior to connecting the iv tubing to the patient.There was no patient harm.Photo of the iv tubing was provided by the customer.
Additional Manufacturer Narrative
The customer¿s report that the tubing came apart below the drip chamber was confirmed.Visual inspection observed a separation at the engagement of the drip chamber¿s outlet port.The remainder of the set was not returned for investigation.Functional testing could not be conducted due to the separation.The root cause of the customer¿s experience was a manufacturing issue due to insufficient solvent being applied at the junction of the tubing.
Event or Problem Description
It was reported that the rn spiked the bag of iv potassium iv piggyback using secondary tubing and the tubing came apart below the drip chamber.The event occurred prior to connecting the iv tubing to the patient.There was no patient harm.Photo of the iv tubing was provided by the customer.

• Brand Name: ALARIS® SECONDARY ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9084072
• Report Number: 9616066-2019-02623
• Device Sequence Number: 11472514
• Product Code: FPA
• UDI-Device Identifier: 10885403222603
• UDI-Public: 10885403222603
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: MS3500
• Device Catalogue Number: MS3500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 81