Catalog Number 10220 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
|
Patient Problem
Hemolysis (1886)
|
Event Date 11/14/2023 |
Event Type
malfunction
|
Event Description
|
The customer reported to terumo bct customer support that during a therapeutic plasma exchange (tpe) procedure hemolysis was observed in the plasma at the top of the cassette.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.
|
|
Manufacturer Narrative
|
Lot number is not available at this time.Investigation is in process, a follow-up report will be provided.
|
|
Manufacturer Narrative
|
Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Investigation is in process, a follow-up report will be provided.
|
|
Event Description
|
The customer reported to terumo bct customer support that during a therapeutic plasma exchange (tpe) procedure hemolysis was observed in the plasma at the top of the cassette.The customer declined to provide patient information, outcome, procedural details and lot information.The collection set is not available for return because it was discarded by the customer.
|
|
Event Description
|
The customer reported to terumo bct customer support that during a therapeutic plasma exchange (tpe) procedure hemolysis was observed in the plasma at the top of the cassette.The customer declined to provide patient information, outcome, procedural details and lot information.The collection set is not available for return because it was discarded by the customer.
|
|
Manufacturer Narrative
|
Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.A disposable complaint history search was not performed as the customer did not provide the lot number.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause for hemolysis could not be determined but it is likely due to one or a combination of the possible causes listed below: patient's underlying disease state.Patient's medication and/or medical treatment.Hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.Hemolysis due to pinched return line resulting in rbc¿s exposed to pressure drop in return line.Hemolysis due to pinched inlet line resulting in rbcs exposed to pressure drop in inlet line.Hemolysis due to an occlusion in the tubing resulting in rbcs exposed to a pressure drop.
|
|
Search Alerts/Recalls
|