MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. PCA ASV MICROBORE; INTRAVASCULAR ADMINISTRATION SET

Model Number	30883
Medical Device Problem Codes	Stretched (1601); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the pca asv microbore tubing had ballooned near where it entered into the channel, and the pump was stopped with the remaining "28.6ml" of "doxorubicin".This complaint was created to capture the 4th of 6 related incidents.The following information was provided by the initial reporter: "date reported: 2/25; extent of harm: reached the individual: ballooning of iv tubing product.Item: alaris pump iv module & bd alaris 3-port tubing: item and lot number: being investigated currently.Item currently being reviewed by clinical engineering alongside with the alaris channel.Doxorubicin medication pump continued to state that "patient side was occluded",no visible occlusion or bent tubing, once i opened the channel on pump, visible ballon on tubing that goes inside channel.Pump was stopped with 28.6ml remaining of medication.".
Event or Problem Description
It was reported that the pca asv microbore tubing had ballooned near where it entered into the channel, and the pump was stopped with the remaining "28.6ml" of "doxorubicin".This complaint was created to capture the 4th of 6 related incidents.The following information was provided by the initial reporter: "date reported: 2/25; extent of harm: reached the individual: ballooning of iv tubing product.Item: alaris pump iv module & bd alaris 3-port tubing: item and lot number: being investigated currently.Item currently being reviewed by clinical engineering alongside with the alaris channel.O doxorubicin medication pump continued to state that "patient side was occluded",no visible occlusion or bent tubing, once i opened the channel on pump, visible ballon on tubing that goes inside channel.Pump was stopped with 28.6ml remaining of medication.".
Additional Manufacturer Narrative
The following fields were updated due to corrected information: device available for eval?: no.Returned to manufacturer on: na.Investigation: a complaint of tubing ballooning was received from the customer.A photo was provided to aid in the investigation of this defect.In the photo it was observed that the tubing below the upper filament was ballooning during infusion.The customer complaint was verified.A device history record review could not be performed on model 30883 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: PCA ASV MICROBORE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• MDR Report Key: 11571255
• Report Number: 9616066-2021-50566
• Device Sequence Number: 4205921
• Product Code: FPA
• UDI-Device Identifier: 50885403273955
• UDI-Public: 50885403273955
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: 30883
• Device Catalogue Number: 30883
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1