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

Model Number 201-90052

Device Problems Product Quality Problem (1506); No Apparent Adverse Event (3189)

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

Event Date 05/27/2022

Event Type  malfunction  

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the hard case that was supposed to contain a pedimag was empty.

Manufacturer Narrative

Manufacturer's investigation conclusion: no device related issues were reported.No product has been received to date.The device history record for centrimag blood pump lot # l07509-lb4 was reviewed and showed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump instructions for use (ifu) lists adverse events, warnings, and cautions regarding the use of the centrimag circulatory support system: 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.

Event Description

It was reported that the hard case that was supposed to have a pedimag pump was empty; however, it was later found that the case was in fact not ¿empty.¿ a clinician at the account had placed the case back on the shelf and when trying to prime a pump in a hurry grabbed the already used pump case.

• Brand Name: PEDIMAG 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 CA CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14687259
• MDR Text Key: 296767082
• Report Number: 2916596-2022-11358
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140634
• UDI-Public: 07640135140634
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

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 Expiration Date: 05/03/2024
• Device Model Number: 201-90052
• Device Catalogue Number: 201-90052
• Device Lot Number: L07509-LB4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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