MAUDE Adverse Event Report: MEDTRONIC INC. AFFINITY CP; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number AP 40

Device Problems Coagulation in Device or Device Ingredient (1096); Improper Flow or Infusion (2954); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2020

Event Type  malfunction  

Event Description

It was noted that the venous side of the continuous veno-venous hemofiltration (cvvh) had been moved to pre-pump at some point this week.Almost 2 hours later, the clots on the pre-membrane side of oxygenator were noted.Approximately one hour later, it was noted that the pump head had creamy/pink/opaque looking color to most of the pump head.Patient stable and no noise or other irregularities of the pump head noted.About 2 hours later, someone was consulted to assess pump head, due to clicking/metallic noise and pump head feeling strange to touch.Soon, perfusion paged fyi about pump head.About 15 minutes later, ecmo flows started fluctuating from 4.72-4.96.The pump went down.Albumin administered, vent increased to 100% o2, charge rt and dr.Were notified.Hand cranked until new ecmo circuit placed.About 1.5 hours later, a new ecmo circuit was reconnected and cvvh placed inline to pre/post-membrane.

• Brand Name: AFFINITY CP
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): MEDTRONIC INC.; 710 medtronic parkway; minneapolis MN 55432 5604
• MDR Report Key: 10958366
• MDR Text Key: 219915556
• Report Number: 10958366
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/06/2020

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 Model Number: AP 40
• Device Lot Number: 220257584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1