MAUDE Adverse Event Report: HAEMONETICS CORP. MCS+ MOBILE COLLECTION SYSTEM

Catalog Number 09000-220-E

Device Problem Increase in Pressure (1491)

Patient Problems Fainting (1847); Infiltration into Tissue (1931); Venipuncture (2129); Reaction (2414); Diaphoresis (2452); Pallor (2468)

Event Date 07/09/2014

Event Type  Injury  

Event Description

Haemonetics received a report on (b)(6) 2014 for a mcs+ device with a donor adverse reaction.A phone call from the customer was received stating that during a universal platelet protocol (upp) procedure, the donor experienced an adverse reaction during the sixth cycle of the procedure.The donor was feeling faint with diaphoresis and paleness.The device displayed a high pressure at the donor pressure monitor message and then the donor's vein blew.The procedure was discontinued.The donor was placed in (b)(6) position.There was no change in symptoms over the next five minutes and the donor was transferred within the center to the clinical room where 500ml of glucose 5% solution was administered via iv.An additional 150ml was given and the donor improved significantly.An hour post infusion, the donor departed the center in good condition.The center received a phone call a few hours later from the donor stating that she was transported to the hospital after fainting on the bus.The donor was given a doctor letter for three days of no work.Follow up with the donor found no issues since this incident.

Manufacturer Narrative

A haemonetics field service engineer went to the center to evaluate the device.A complete diagnostics was completed with no malfunctions found with the device.A review of the data logs from the procedure showed that the device performed as expected and alerted the operator that there was high pressure on the donor line.A statement from the customer to the (b)(4) regulatory agency stated that this donor has a history of adverse experiences with donation.(b)(4).

• Brand Name: MCS+ MOBILE COLLECTION SYSTEM
• Manufacturer (Section D): HAEMONETICS CORP.; 400 wood rd.; p.o. box 9114; braintree MA 02184
• Manufacturer Contact: julie smith,rn ; 400 wood rd.; p.o. box 9114; braintree, MA 02184 ; 7819170643
• MDR Report Key: 4027806
• MDR Text Key: 4728564
• Report Number: 1219343-2014-00025
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK080038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 09000-220-E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/1998
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 42 YR
• Patient Weight: 69