MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM; CELL SAVER ELITE SET - 125ML

Model Number CSE-P-125-JA

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020 haemonetics manufacturing performed a visual inspection of the received 125 ml bowl from the cell saver elite set and confirmed blood in the inner core with 1 bowl crack in the inner core base.Although there was no serious injury or harm, past reporting (1219343-2020-00001-01) indicates this particular malfunction on a similar device has been associated with a reported death event.The investigation of 1219343-2020-00001-01 indicated the inner core of the bowl malfunctioned via a crack but did not cause or contribute to the reported incident according to the surgeon that performed the surgery.Haemonetics decided to conservatively report inner core cracks that are confirmed by manufacturing evaluation due the event of the past report.

Event Description

On (b)(6) 2020 haemonetics (b)(6) was informed by customer (b)(6) medical center while utilizing the cell saver® elite® plus system and cell saver® elite set - 125ml during the bood return phase at the end of the bentall total-arch openstent procedure they received an error "long blood return".When the bowl was removed, blood was flowing inside the core.The bowl was replaced with a new one.The onset cycle was about 15 to 16 during and after surgery.There was no reported impact to patients' health.

• Brand Name: CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM
• Type of Device: CELL SAVER ELITE SET - 125ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: miranda holland ; 125 summer street; boston, ma ; 8487100
• MDR Report Key: 10421320
• MDR Text Key: 205685284
• Report Number: 1219343-2020-00080
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/11/2020

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 Expiration Date: 01/13/2023
• Device Model Number: CSE-P-125-JA
• Device Lot Number: 0120047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2020
• 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