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

Model Number	2200-0500
Medical Device Problem Codes	Collapse (1099); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Patient age and dob requested but not provided by the customer.
Event or Problem Description
The customer reported that the iv tubing set is collapsing on itself while infusing tpn via the patient's central line, thereby causing the pump to alarm occlusion or bag empty.The customer was unable to resolve the issue and had to discard the bag of tpn and put the patient on "clears" for the rest of the night.There was no report of patient harm.
Additional Manufacturer Narrative
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 iv tubing set is collapsing on itself while infusing tpn via the patient's central line, thereby causing the pump to alarm occlusion or bag empty.The customer was unable to resolve the issue and had to discard the bag of tpn and put the patient on "clears" for the rest of the night.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report that the tubing collapsing on itself causing occlusion alarms was confirmed.Visual inspection of the set noted that the top half of the tubing was still coiled and taped and that the tubing was kinked around the tape.There were no other anomalies observed.Initially, the as-received set could not be primed due to the kinked tubing around the taped, uncoiled section.After the tape was removed and the tubing was straightened out, fluid flowed freely.The set passed pressure testing without issues.The root cause of the report that the set was collapsing and causing occlusion alarms was due to the kinks in the top half of the set from it being coiled and taped.
Event or Problem Description
The customer reported that the iv tubing set is collapsing on itself while infusing tpn via the patient's central line, thereby causing the pump to alarm occlusion or bag empty.The customer was unable to resolve the issue and had to discard the bag of tpn and put the patient on "clears" for the rest of the night.There was no report of patient harm.

• 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: 8286446
• Report Number: 9616066-2019-00201
• Device Sequence Number: 16185010
• Product Code: FPA
• UDI-Device Identifier: 07613203012638
• UDI-Public: 7613203012638
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2019

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 Expiration Date: 11/02/2021
• Device Model Number: 2200-0500
• Device Catalogue Number: 2200-0500
• Device Lot Number: 18115259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 02/21/2019; 04/02/2019
• 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: 8100,8015,CENTRAL LINE, THERAPY DATE
• Patient Age: 8 DA