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

Model Number MS3500-15

Device Problems Insufficient Flow or Under Infusion (2182); Failure to Infuse (2340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 250ml baxter bag, lot: y309807, exp dec20, 0.9% sodium chloride injection; 100ml pfizer galaxy bag lot: ln118323, exp 19feb20, zosyn 4.5g (piperacillin and tazobactam injection); one alcohol cap.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.The customer stated that the patient was an adult patient.

Event Description

It was reported that the secondary antibiotic therapy piperacillin-tazobactam (zosyn) 4.5g/d5 100ml to be administered every 8 hours for a duration of 4 hours was hung at 0423.At 0715, the primary infusion of normal saline was found to be infusing instead of the antibiotic.Upon assessment, it was found that the secondary tubing set was unclamped and appeared to have partially infused.The infusion was stopped at 0715 and it is unknown how much of the antibiotic medication was infused.The customer further stated that there were no adverse effects caused to the adult patient from the event.

Manufacturer Narrative

Additional info: the suspect instrument is changed from a tubing set to a device.Please reference manufacturer report number 2016493-2019-01443 from emdr 332078.

Event Description

It was reported that the secondary antibiotic therapy piperacillin-tazobactam (zosyn) 4.5g/d5 100ml to be administered every 8 hours for a duration of 4 hours was hung at 0423.At 0715, the primary infusion of normal saline was found to be infusing instead of the antibiotic.Upon assessment, it was found that the secondary tubing set was unclamped and appeared to have partially infused.The infusion was stopped at 0715 and it is unknown how much of the antibiotic medication was infused.The customer further stated that there were no adverse effects caused to the adult patient from the event.

• 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: 9089130
• MDR Text Key: 159330075
• Report Number: 9616066-2019-02614
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403222610
• UDI-Public: 10885403222610
• Combination Product (y/n): N
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

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
• Device Operator: Health Professional
• Device Model Number: MS3500-15
• Device Catalogue Number: MS3500-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (2).8100,.8015,.PRI TUBING, TD (B)(6) 2019