MAUDE Adverse Event Report: HAEMONETICS CORP PCS®2 PLASMA COLLECTION SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC,

Model Number 06002-CP-110

Device Problem Calibration Problem (2890)

Patient Problems Dyspnea (1816); Chest Tightness/Pressure (2463)

Event Date 06/15/2017

Event Type  Injury  

Manufacturer Narrative

The haemonetics field service engineer (fse) evaluated the machine.The fse ran a complete visual and diagnostics check on machine.When testing the donor pressure monitor (dpm) in diagnostics, the initial reading was within specification.After gradually releasing pressure on the sphygmomanometer, the pressure gradually increased to a value of 306 on the display.As pressure decreased on the sphygmomanometer to a read out of 280, read out of dpm on display started to decrease.The dpm was recalibrated and tested dpm pressure again in diagnostics.The same behavior was observed.The old cpu pcb was replaced with a new cpu pcb.New cpu pcb resolved the issue.During the next test of donor pressure in diagnostics the sphygmomanometer pressure and the machine read out of dpm pressure decreased in unison as the pressure on the sphygmomanometer was released.The machine meets manufacturer specifications and was put back into service.

Event Description

Haemonetics received a report on 06/15/2017, that during a routine plasmapheresis on the pcs¿plasma collection system, a donor began experiencing chest pain and tightness and shortness of breath after receiving an alarm of "air in the donor line." this alarm occurred during the first draw cycle of the procedure.The phlebotomist ended the procedure and the donor had an estimated rbc loss of less than 200 ml as there was no return cycle attempted.It is unknown if any air went back to the donor.Only 1 ml of plasma was collected and 21 ml of saline was administered.It was documented that the saline bag swelled, the blood line was clear and blood was in the bowl.Ems was called to the center for the donor's symptoms and o2 was given via face mask.Ems arrived and the donor was administered 325 mg of aspirin and an ekg was performed by the emt.The donor was taken to the local emergency room.An mri was ordered, but no results are available therefor it cannot be confirmed if any air actually was pushed to the donor.The donor was kept overnight on o2 to monitor her breathing and discharged the following day.No other information was available.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC,
• Manufacturer (Section D): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer Contact: julie smith, rn ; 400 wood rd; braintree, MA 02184 ; 7819170643
• MDR Report Key: 6691000
• MDR Text Key: 79234660
• Report Number: 1219343-2017-00013
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK920039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2017

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: Phlebotomist
• Device Model Number: 06002-CP-110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR
• Patient Weight: 100