MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS2 PLASMA COLLECTION SYSTEM; PCS2, LIST NO. 06002-CP-220, PRODUCT CODE: GKT

Model Number 06002-CP-220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Movement Disorder (4412); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Manufacturer Narrative

During a literature review, it was noted that in an off-label retrospective review of patients undergoing tpe with underlying neurological conditions using hae equipment.It is stated that a majority of events resolved with no intervention required.While no device malfunction is alleged, a causal relationship between the procedures and events could not be ruled out in the 15 events of citrate reactions and 6 events of hypotensive symptoms.It is unknown if these adverse were previously reported, but in hae's commitment to patient safety, these events are being reported out of abundance of caution.

Event Description

During a review of a published literature article of an off-label retrospective review of the complications of therapeutic plasma exchange (tpe) in patients with neurologic disorders and its predisposing factors.In the study, there is alleged device malfunction.A review of the numerous aes listed could link the possible citrate reactions (n=15) and hypotensive symptoms (n=6).As stated there was no alleged device malfunction and the events are being reported in an abundance of caution and hae's commitment to patient safety.

• Brand Name: PCS2 PLASMA COLLECTION SYSTEM
• Type of Device: PCS2, LIST NO. 06002-CP-220, PRODUCT CODE: GKT
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 12614931
• MDR Text Key: 275902270
• Report Number: 1219343-2021-00133
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK950033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/07/2021

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 Model Number: 06002-CP-220
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other