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

Model Number 2426-0007

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 01/21/2020

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.

Event Description

It was reported a slice in the tubing.Patient impact has been requested, but not yet provided.

Manufacturer Narrative

The customer¿s report of a slice in the tubing was confirmed.Visual inspection of the set noted a small tear.The clear cap was present on the male luer and the pinch clamp was engaged.No other issue was observed.Functional testing confirmed leaking from the tear in the tubing.The root cause of the slice in the tubing was not identified.

Event Description

It was reported that in the ic there was a slice in the tubing attached to one 100ml baxter bag, 0.9% sodium chloride injection.It was reported that patient care was not delayed and it did not contribute to, or result in serious adverse impact to patient.

Manufacturer Narrative

Correction on initial repot: b.4 & g.4.

Event Description

It was reported that a tear and leak was observed in the tubing while 100ml 0.9% sodium chloride was infusing.Event occurred in intensive care unit.It was reported that patient care was not delayed and it did not contribute to, or result in serious adverse impact to patient.

Manufacturer Narrative

Additional information provided: b.3, b.5, d.4, d.11 & h.4.Although requested, patient demographics was not provided.

Event Description

It was reported that a tear and leak was observed in the tubing while 100ml 0.9% sodium chloride was infusing.Event occurred in intensive care unit.It was reported that patient care was not delayed and it did not contribute to, or result in serious adverse impact to patient.

• 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: 9702455
• MDR Text Key: 179433957
• Report Number: 9616066-2020-00479
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• 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,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/28/2020

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 Expiration Date: 12/12/2022
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 19126072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/02/2020; 03/04/2020; 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 100ML BAXTER BAG, THERAPY DATE UNK; THERAPY DATE (B)(6) 2020