MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 201-90010

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the photograph submitted by the account, on-site photographs taken by an abbott representative, and device history record (dhr) documentation did not confirm any issues with the received packaging or product labels for centrimag blood pump.On 16jan2020, the physician reported concerns regarding the labels applied on the packaging of centrimag products that had been received at the hospital.It was stated that the product labels appeared different than the labels applied on centrimag packaging previously received at the hospital.The physician submitted photographs of four blood pump cases, two of which were identified as centrimag blood pump per the information printed on the pump case labels.The pump case for centrimag blood pump was not returned to abbott for evaluation; however, an on-site inspection of the pump case and its internal contents was conducted by the abbott regional security manager.The pump case and internal contents were in the intended condition and all seals remained intact.No damage to the blood pump or its tray packaging was observed.The product labels applied on the pump case, unit box, and outer tray matched the product labels from manufacturing scanned within the dhr with no difference in use by date.A complete review of the device history record, including the verification of proper packaging and labeling, revealed that centrimag blood pump was manufactured in accordance with manufacturing and quality assurance specifications.Each respective label for the pump case, unit box, and outer tray were correctly manufactured with the intended use by date of 2022-02-28.The ous centrimag vad ifu explains that the centrimag vad is sterile and non-pyrogenic in an unopened and undamaged unit package.The user is warned to inspect each package and device carefully prior to use and not to use if any sterile seals are broken or if the package is opened or damaged.This document also instructs the user to check the date and integrity of the sterile centrimag vad package and warns that a back-up centrimag vad and components must always be available.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Labeling concern was reported, that the labels are different from usual labels received.No further information was provided.

• Brand Name: CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS
• 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: 10049609
• MDR Text Key: 191540565
• Report Number: 0002916596-2020-02533
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2020

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: Lay User/Patient
• Device Expiration Date: 02/28/2022
• Device Model Number: 201-90010
• Device Lot Number: L06324-LA7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1