MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM; LOW VOL(125ML) CS5 SET

Model Number 0261J-00

Device Problem Crack (1135)

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

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

On aug 7, 2020, haemonetics manufacturing performed a visual inspection of the received bowl from the low vol(125ml) cs5 set and confirmed blood in the inner core with six (6) bowl cracks 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 due the event of the past report.

Event Description

On (b)(6) 2020, haemonetics (b)(4) was informed by customer (b)(6) geriatric medical center during an orthopedic surgery an inner core leak was observed on the 2nd cycle during the empty phase while utilizing the cell saver 5 autologous blood recovery system and low vol(125ml) cs5 set.There was no reported impact to patients' health.

• Brand Name: CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
• Type of Device: LOW VOL(125ML) CS5 SET
• 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: 10421309
• MDR Text Key: 204763582
• Report Number: 1219343-2020-00077
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K014083
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0261J-00
• Device Lot Number: 0919020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2019
• 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