MAUDE Adverse Event Report: HERMAC MEDICAL PRODUCTS ECP (PHOTOPHERESIS)

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem No Code Available (3191)

Event Date 03/01/2014

Event Type  Injury  

Event Description

A case of hemagglutination that occurred in a patient with cold agglutinin disease (cad) undergoing ecp was reported in the journal of american academy of dermatology.[mask-bull, lisa m.D."hemagglutination during photopheresis" journal of american academy of dermatology volume 70, number 3, march 2014, page e61] following a severe outbreak of herpes zoster, the patient was receiving his 25th treatment of ecp when agglutinated blood was noted in the centrifuge bowl, acrylic plates, and tubing.A hemoglobin level obtained at the time was 7.1 g/dl.A direct coombs test was positive for anti-c3d and negative for anti-igg, confirming the diagnosis of cold agglutinin disease.The patient had no further complications.Review of the medical records revealed that in 9 of the patient's complete blood counts over the previous 2 years, the laboratory had commented that the patient's blood sample "required rewarming" and appeared "markedly agglutinated." laboratory results from the previous year showed a progressive decrease in hemoglobin and gradual increases in lactate dehydrogenase and mean corpuscular volume, indicating progression of cad.An increase in the cd4-to-cd8 ratio was also observed, indicating simultaneous progression of ss.These findings suggest that the patient may have had pathologic cold agglutinins (cas) causing low-grade hemolysis and agglutination for 2 years while undergoing ecp.Clues to the diagnosis of cad in our patient include chronic macrocytic anemia, a history of cll, and temperature-dependent hemagglutination.Although his cad and ss were progressing simultaneously, there are no reports of a correlation between the 2 conditions.We attribute the patient's cad to his underlying cll.Hemagglutination may have been precipitated by his recent viral illness and environmental conditions during ecp.We have presented a potentially serious complication that occurred during the use of a therapy that is broadly applied by multiple medical specialties.Awareness of the risk factors, signs, and symptoms of cad, and appropriate pretreatment screening may help avoid this rare but significant adverse event in patients with cas undergoing ecp.".

Manufacturer Narrative

This is an adverse event reported in medical literature.The author presents this case as "a potentially serious complication that occurred during the use of therapy." this case is deemed to be serious and related to ecp therapy.It is not known whether the patient was being treated with the cellex or xts instrument.The kit lot number is unknown.Trends have been reviewed for complaint categories, clot observed and other adverse event, and no trends were detected.Complaints are monitored through tracking and trending.If a trend is observed, further action will be taken.(b)(4).

• Brand Name: ECP (PHOTOPHERESIS)
• Type of Device: ECP (PHOTOPHERESIS)
• Manufacturer (Section G): HERMAC MEDICAL PRODUCTS; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east suite 140; bridgewater, NJ 08807
• MDR Report Key: 4098074
• MDR Text Key: 4700324
• Report Number: 2523595-2014-00231
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR