MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7322-24

Device Problem Improper Flow or Infusion (2954)

Patient Problems Air Embolism (1697); Intracranial Hemorrhage (1891)

Event Date 11/16/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that a cadd® administration set was involved in an incident where the patient had an air embolism to the brain, which resulted in a stroke.The patient had to be hospitalized.The patient was being infused with penicillin when the event occurred.The patient outcome was unknown.See mfr: 3012307300-2017-00580.

Manufacturer Narrative

One cadd-prizm® vip pump was returned for investigation.No accessories were received with the pump.The event history log showed no discrepancy between the doses/volumes delivered and those the clinician intentionally placed under control of the patient via the programmed protocol.A visual inspection showed the pump to be in good condition, and there was no damage observed on the chassis.Functional testing was unable to replicate the reported problem of "air in line".This particular model of the cadd-prizm® vip pump does not contain an air sensor.Three separate delivery accuracy flow tests were performed on the pump and no problems were found.The complaint was not confirmed, and no root cause was determined.

Manufacturer Narrative

He administration set was not returned.A cadd-prizm vip pump was returned and investigated.Review of the pump's event history log showed no discrepancy between the doses/volumes delivered and those the clinician intentionally placed under control of the patient via the programmed protocol.A visual inspection showed the pump to be in good condition, and there was no damage observed on the chassis.Functional testing was unable to replicate the reported problem of "air in line".This particular model of the cadd-prizm vip pump does not contain an air sensor.Three separate delivery accuracy flow tests were performed on the pump and no problems were found.The complaint was not confirmed, and no root cause was determined.No lot number was provided; therefore, a history record review could not be conducted.For all enquires or follow up questions related to the record, do not use (b)(6) located in section g1, please direct those to the following: (b)(6) corrected data: g7: follow-up number.

• Brand Name: CADD® ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6358494
• MDR Text Key: 68308458
• Report Number: 3012307300-2017-00571
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586029640
• UDI-Public: 30610586029640
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-7322-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/24/2017
• Supplement Dates Manufacturer Received: 04/10/2017
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CADD-PRIZM VIP PUMP (SERIAL #: (B)(6)); CADD-PRIZM VIP PUMP (SERIAL #: (B)(4))
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention