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

Model Number 10013890

Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Information (3190)

Event Type  malfunction  

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.Additional information including patient's demographics requested, but was not provided.

Event Description

It was reported that the iv tubing set appeared to have micro holes where fluid seemed to be seeping from the tubing where the cartridge is inserted into pump.

Event Description

It was reported that the iv tubing set appeared to have micro holes where fluid seemed to be seeping from the tubing where the cartridge is inserted into pump.

Manufacturer Narrative

Correction on initial report: g.3 (disregard other & not provided).

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10046525
• MDR Text Key: 195955709
• Report Number: 9616066-2020-01557
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232268
• UDI-Public: 10885403232268
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

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
• Device Operator: Health Professional
• Device Model Number: 10013890
• Device Catalogue Number: 10013890
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8100, THERAPY DATE UNK