MAUDE Adverse Event Report: PERFUSION SYSTEMS CUSTOM PACK CB1Q91R6 NTUH CCS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number CB1Q91R6

Device Problem Crack (1135)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 09/16/2020

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use, the customer reported the bpx-80 adult bio-pump¿ plus centrifugal pump leaked, and the patient had a large blood loss.The patient was on ecmo on (b)(6) 2020 at 4 pm.At 10pm the patient had bp dropped and cpr was performed.The nurse then found the bio-pump was leaking, so they called the perfusionist.The perfusionist tried to change bio-pump.The patient lost a lot of blood and expired at 10.30 pm.The customer thought the bio-pump may be one of the causes of patient death.Additional information received on october 15th 2020, stated the leak was at the connector between the blood outlet and tubing, and that when the perfusionist was removing the pump head from the external drive, she found the tubing disconnected from the blood outlet easily.Patient medical history: allergy, lung problems.

Manufacturer Narrative

Medtronic investigation: a visible leak was noted from the outlet of the pump.Additional information received from the user stated the location of the leak was at the connection between the outlet and tubing, and the user found the tubing disconnected from the outlet easily.Because the device was not returned, the root cause of this complaint could not be determined.Review of the dhr found no abnormalities during the manufacturing process.A clinical review of this event concluded there are no new risks associated with the use of this device.Trends for issues with this product are reviewed at quarterly quality meetings.This investigation was completed with the information that was provided.If additional information is received this investigation will be reopened if deemed necessary.No further actions to be taken at this time.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use, the customer reported the bpx-80 adult bio-pump® plus centrifugal pump leaked, and the patient had a large blood loss.The patient was on ecmo on (b)(6) 2020 at 4 pm.At 10pm the patient had bp dropped and cpr was performed.The nurse then found the bio-pump was leaking, so they called the perfusionist.The perfusionist tried to change bio-pump.The patient lost a lot of blood and expired at 10.30 pm.The customer thought the bio-pump may be one of the causes of patient death.Additional information received on (b)(6) 2020, stated the leak was at the connector between the blood outlet and tubing, and that when the perfusionist was removing the pump head from the external drive, she found the tubing disconnected from the blood outlet easily.Patient medical history: allergy, lung problems.

• Brand Name: CUSTOM PACK CB1Q91R6 NTUH CCS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10807877
• MDR Text Key: 215247700
• Report Number: 2184009-2020-00074
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K171308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2022
• Device Model Number: CB1Q91R6
• Device Catalogue Number: CB1Q91R6
• Device Lot Number: 219499956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 11 YR
• Patient Weight: 22