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

Model Number 2426-0500

Device Problems Crack (1135); Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: microclave, therapy date (b)(6) 2018.Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

The customer reported that during an infusion of an anti-rejection drug used for a kidney transplant patient, the thymoglobulin tubing had a crack and leak next to roller clamp below second port and clamp.There was a delay while the nurse obtained a new bag of medication and tubing.No patient harm was reported.

Event Description

The customer reported that during an infusion of an anti-rejection drug used for a kidney transplant patient, the thymoglobulin tubing had a crack and leak next to roller clamp below second port and clamp.There was a delay while the nurse obtained a new bag of medication and tubing.No patient harm was reported.

Manufacturer Narrative

Additional information provided.The customer¿s report that the tubing cracked and leaked next to the roller clamp was confirmed.Visual inspection of the set noted a hole in the tubing just distal to the middle smartsite near the roller clamp.The edges of the hole were uneven and jagged.No other anomalies was observed.Functional testing confirmed leaking from the hole.The root cause was not identified.

Manufacturer Narrative

Additional information provided.The customer¿s report that the tubing cracked and leaked next to the roller clamp was confirmed.Visual inspection of the set noted a hole in the tubing just distal to the middle smartsite near the roller clamp.The edges of the hole were uneven and jagged.No other anomalies was observed.Functional testing confirmed leaking from the hole.The root cause was not identified.

Event Description

The customer reported that during an infusion of an anti-rejection drug used for a kidney transplant patient, the thymoglobulin tubing had a crack and leak next to roller clamp below second port and clamp.There was a delay while the nurse obtained a new bag of medication and tubing.No patient harm was reported.

• 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: 7638107
• MDR Text Key: 112417839
• Report Number: 9616066-2018-00884
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Other Device ID Number: 7613203020992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 10013902; 8015,8100,ICU MEDICAL, TD (B)(6) 2018
• Patient Age: 49 DA