MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102953

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Septic Shock (2068); Vomiting (2144); Fungal Infection (2419); Respiratory Failure (2484); Thrombocytopenia (4431)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that on (b)(6) 2018 the patient had candida parapsilosis fungemia and on (b)(6) 2018 the patient had a positive blood culture for acinetobacter carbapenem-resistant enterobacteriaceae type.Their sputum culture was also positive for pseudomonas aeruginosa and stenotrophomonas maltophilia in sputum.They were received polymyxin b, meropenem, minocycline, and micafungin.The patient also had vancomycin-resistant enterococcus faecium in their gallbladder fluid and were placed on linezolid.Bile fluid cultures were positive for pseudomonas.They had a wound vacuum-assisted closure (vac) on their sternal wounds which was not healing.A sternal culture was positive for vancomycin-resistant enterococcus faecium.On (b)(6) 2018 they were brought to the operating room (or) for debridement and wound vac.Repeat cultures taken of the drainage was positive for enterococcus faecium and acinetobacter.Their lactate dehydrogenase (ldh) was elevated but improving.Between (b)(6) 2018 the patient received two units of blood and appeared more somnolent.Related heartmate 3 lvad mfr# 2916596-2022-12780.

Event Description

On (b)(6) 2018 a computed tomography (ct) scan of the patient¿s abdomen was conducted to rule out mesenteric ischemia.The ct scan showed colitis in the ascending colon to hepatic flexure and ischemic colitis was brought into question.The patient¿s white blood cell (wbc) count was noted to be elevated and the patient did not have a fever.A colonoscopy was conducted on 04nov2018 and was found to be normal.The patient had increased vasopressor requirements due to persistent low mean arterial pressures (maps).The patient ultimately developed thrombocytopenia from linezolid.The patient was noted to have lactic acidemia without improvement despite a prolonged antibiotic course.It was later reported that the patient¿s lactate levels remained elevated but were observed to be improving.The patient¿s prognosis still remained poor, and the patient¿s overall condition was discussed with their partner.A meeting with the patient¿s family was held and the family was provided with very good insight into the patient¿s prognosis.The patent¿s care was continued with no escalations.The patient passed away on (b)(6) 2018 due to sepsis.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events as well as a direct correlation to the centrimag blood pump could not be conclusively determined through this evaluation.The device was not returned for evaluation.The device history record for centrimag blood pump lot #l05505-la7 was reviewed and showed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump instructions for use (ifu) (rev.09) lists infection, bleeding, respiratory failure, hypotension, and death as adverse events that may be associated with the centrimag circulatory support system under ¿adverse events¿.This ifu also provides the following warnings and cautions: ifu warning #7: it is intended that systemic anticoagulation be utilized while this device is in use.Anticoagulation levels should be determined by the physician based on risks and benefits to the patient.Ifu warning #10: frequent patient and device monitoring is recommended.Ifu warning #13: the pump must be handled in an aseptic manner until primed and connected to a closed tubing circuit.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15285733
• MDR Text Key: 298565155
• Report Number: 3003306248-2022-12498
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 7640135140627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 102953
• Device Lot Number: L05505-LA7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2018
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White