MAUDE Adverse Event Report: SMITHS MEDICAL CADD ADMINISTRATION SETS

Device Problems Air Leak (1008); Insufficient Flow or Under Infusion (2182)

Patient Problem No Information (3190)

Event Date 02/26/2016

Event Type  malfunction  

Event Description

We tested cadd administration sets 7382, 7381m abd 7394 prior to implementing the cadd solis vip ambulatory pumps in our healthcare organization.We submitted 34 complaints and sets for investigation to smiths medical, august 28, 2015 thru 11/09/2015 (yes, 2015) for air-in-lines (24 complaint set 7381)and 8 underinfusion complaints (set 7394).We have individual reports and email trails on all of these submitted.Smiths investigated the first two sets submitted in august - tested them on a different cadd pump, and sent us a closure letter december 23 (no findings).This is outside the timeframes for complaint handling and quality systems.We awaited results of investigation of the rest of the sets submitted.February 2016, we were verbally told by smiths that they simply closed all the other complaints.We never did get closure letters.So we insisted smiths come and witness the problems themselves, then go and fix them.They attended our site for pump and set testing august 2015 "200795 2 sets, one ref # "21-7383-24 45x373 in 2 out of 3 tests we have noted air below the filter.We utilize the filters to remove air in home patients to prevent an air emboli.Tubing were primed by two different people following the manufacturer's recommendations and including tapping of the filter as recommended by company representative.Both were primed to pump with at least 8 ml of fluid and the rib side appeared to be saturated with fluid during the priming process.Air first noted after the administration of the first dose.Once it started it seemed to continue to occur throughout the infusion.On (b)(6) 2015 201727 21-7381-24 air noted distal to the air filter after priming according to manufacturer's instructions.Problem noted through out infusion with any movement of the tubing.This poses a potential air embolism risk for patients.Problem reoccurred with repeat demonstration (3 out of 3 times) with smith medical rep present to ensure priming technique was correct.On (b)(6) 2015, 201728 21-7381-24 air noted distal to the air filter after priming according to manufacturer's instructions.Problem noted throughout infusion with any movement of the tubing.This poses a potential air embolism for patients.Problem reoccurred with repeat demonstration (3 out of 3 times) with smiths medical rep present to ensure priming technique was correct.On (b)(6) 2015 201730 21-7383-24 air noted distal to the air filter after priming according to manufacturer's instructions.Problem noted throughout infusion with any movement of the tubing.This poses a potential air embolism for patients.Problem reoccurred with repeat demonstration (3 out of 3 times) with smiths medical rep present to ensure priming technique was correct.On (b)(6) 2015 clarify filter, lot september 18-24" (b)(6) 2015 201729 21-7383-24 45x373 air noted distal to the air filter after priming according to manufacturer's instructions.Problem noted throughout infusion with any movement of the tubing.This poses a potential air embolism for patients.Problem reoccurred with repeat demonstration (3 out of 3 times) with smiths medical rep present to ensure priming technique was correct.Total 4 sets for this report.On (b)(6) 2015 requested 203731 21-7383-01 44x502 when priming tubing with cadd pump, air continued to be present in bubbles and up to 10cm of air at a time after the air filter.We tested on 4 tubings with 4 different pumps and all had air, and all from the same lot # and product #.On (b)(6) 2015 203748 21-7383-01 44x502 when priming tubing with cadd pump all continued to be present in bubbles and up to 10cm of air at a time after the air filter.We used actual medication bags one with cefazolin and primed as we would teach families, using the prime on the pump.There continued to be air present in the tubing distal to the air filter in a 24 hour period, and was worse when tubing moved around as it would be when being worn by a patient.On (b)(6) 2015 203750 21-7383-01 44x502 when priming tubing with cadd pump, air continued to be present in bubbles and up to 10cm of air at a time after the air filter.We used actual medication bags one with cefazolin and primed as we would teach families, using the prime of the pump.There continued to be air present in the tubing distal to the air filter in a 24 hour period, and was worse when tubing moved around as it would be when being worn by a patient.On (b)(6) 2015 203743 21-7383-01 44x502 when priming tubing with cadd pump, air continued to be present in bubbles and up to 10cm of air at a time after the air filter.We used actual medication bags one with cefazolin and primed as we would teach families, using the prime of the pump.There continued to be air present in the tubing distal to the air filter in a 24 hour period, and was worse when tubing moved around as it would be when being worn by a patient.On (b)(6) 2015 203745 21-7383-01 44x502 when priming tubing with cadd pump, air continued to be present in bubbles and up to 10cm of air at a time after the air filter.We used actual medication bags one with cefazolin and primed as we would teach families, using the.On (b)(6) 2015 203733 21-7383-24 445x02 air eliminating filter is not eliminating air.Allowing air bubbles distal to the filter.On (b)(6) 2015 203736 21-7383-24 445x02 air eliminating filter is not eliminating air.Allowing air bubbles distal to the filter.On (b)(6) 2015 203737 21-7383-24 445x02 air eliminating filter is not eliminating air.Allowing air bubbles distal to the filter.On (b)(6) 2015 203747 21-7383-24 445x02 air eliminating filter is not eliminating air.Allowing air bubbles distal to the filter.On (b)(6) 2015 requested 203716 21-7383-24 45x428 air eliminating filter is not eliminating air.Allowing air bubbles distal to the filter.On (b)(6) 2015 203717 21-7383-24 45x428 air eliminating filter is not eliminating air.Allowing air bubbles distal to the filter.On (b)(6) 2015 203719 21-7383-24 45x428 air eliminating filter is not eliminating air.Allowing air bubbles distal to the filter.On (b)(6) 2015 203718 21-7383-24 45x428 air eliminating filter is not eliminating air.Allowing air bubbles distal to the filter.On (b)(6) 2015 requested to 62-66 203743 21-7383-24 45x428 air eliminating filter is not eliminating air.Allowing air bubbles distal to the filter.On (b)(6) 2015 203745 21-7383-24 45x428 air eliminating filter is not eliminating air.Allowing air bubbles distal to the filter.On (b)(6) 2015 203710 21-7383-24 45x428 air eliminating filter is not eliminating air.Allowing air bubbles distal to the filter.The 204287 21-7394-24 45x317 under-infusion: penicillin g 24 mu/d5w 600 iv medication bag connected to tubing and pump programmed to deliver doses of medication -4mu iv q4h, with kvo of 2ml/hr.After pump stated that doses were given, there was still m.We have a detailed spreadsheet with the testing undertaken by our organization due to the lack of performance, complaint handling, and quality systems experienced with smiths.

• Brand Name: CADD ADMINISTRATION SETS
• Type of Device: CADD ADMINISTRATION SETS
• Manufacturer (Section D): SMITHS MEDICAL; minneapolis or st. paul
• MDR Report Key: 6198064
• MDR Text Key: 63236454
• Report Number: MW5066841
• Device Sequence Number: 4
• Product Code: FPA
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2016
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2015
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1